Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- CDNUrease, Photometric, Urea Nitrogen2Product Code
- CDOAcid, Uric, Uricase (U.V.)1Product Code
- CDPRadioimmunoassay, Total Triiodothyronine2Product Code
- CDEChromatographic Separation/Zimmerman, 17-Ketosteroids1Product Code
- CHARadioimmunoassay, Corticosterone1Product Code
- CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin1Product Code
- CDGChromatography Separation/Zimmerman 17-Ketogenic Steroids1Product Code
- CDHAcid, Uric, Phosphotungstate Reduction1Product Code
- CDKAcid, Vanilmandelic, Electrophoretic Separation1Product Code
- CDLBerthelot Indophenol, Urea Nitrogen2Product Code
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)1Product Code
- CCYZimmerman (Spectrophotometric), 17-Ketosteroids1Product Code
- CCZZimmerman/Norymberski, 17-Ketogenic Steroids1Product Code
- CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin1Product Code
- CDBPorter Silber Hydrazone, 17-Hydroxycorticosteroids1Product Code
- CDCL-Leucyl B-Naphthylamide, Leucine Aminopeptidase1Product Code
- CDDRadioassay, Vitamin B122Product Code
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen2Product Code
- CDR1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine1Product Code
- CDSElectrode, Ion Specific, Urea Nitrogen2Product Code
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides1Product Code
- CDWDiacetyl-Monoxime, Urea Nitrogen2Product Code
- CDXRadioimmunoassay, Total Thyroxine2Product Code
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone1Product Code
- CEATlc Chromatographic Separation Triglycerides1Product Code
- CECRadioimmunoassay, Free Thyroxine2Product Code
- CED5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase1Product Code
- CEERadioimmunoassay, Thyroxine-Binding Globulin2Product Code
- CEFElectrophoretic, Protein Fractionation1Product Code
- CEIUranyl Acetate/Zinc Acetate, Sodium2Product Code
- CEJTetraphenyl Borate, Colorimetry, Potassium2Product Code
- CEKBiuret (Colorimetric), Total Protein2Product Code
- CELAmmonium Molybdate And Ammonium Vanadate, Phospholipids1Product Code
- CEMElectrode, Ion Specific, Potassium2Product Code
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)1Product Code
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus1Product Code
- CEPRadioimmunoassay, Luteinizing Hormone1Product Code
- CEQMolybdenum Blue Method, Phospholipids1Product Code
- CER2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase2Product Code
- CESChromogenesis, Phenylketones (Urinary, Non-Quant.)1Product Code
- CETOlive Oil Emulsion (Turbidimetric), Lipase1Product Code
- CEWRadioimmunoassay, Parathyroid Hormone2Product Code
- CEXChromatographic Separation, Lactate Dehydrogenase Isoenzymes2Product Code
- CFAElectrode, Ion Specific, Magnesium1Product Code
- CFBChromatographic Derivative, Total Lipids1Product Code
- CFDSulfophosphovanillin, Colorimetry, Total Lipids1Product Code
- CFEElectrophoretic, Lactate Dehydrogenase Isoenzymes2Product Code
- CFGOil Emulsion/Thymolphthalein (Titrimetric), Lipase1Product Code
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase2Product Code
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase2Product Code
- CFLRadioimmunoassay, Human Growth Hormone1Product Code
- CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)1Product Code
- CFOTitrimetric, Magnesium1Product Code
- CFPRadioimmunoassay, Immunoreactive Insulin1Product Code
- CFRHexokinase, Glucose2Product Code
- CFTRadioimmunoassay, Prolactin (Lactogen)1Product Code
- CFWCopper Reduction, Glucose2Product Code
- CGAGlucose Oxidase, Glucose2Product Code
- CGCRadioimmunoassay, Gastrin1Product Code
- CGDFerricyanide, Glucose2Product Code
- CGEOrthotoluidine, Glucose2Product Code
- CGFRadioimmunoassay, Estrone1Product Code
- CGHElectrophoretic, Globulin1Product Code
- CGIRadioimmunoassay, Estriol1Product Code
- CGJRadioimmunoassay, Follicle-Stimulating Hormone1Product Code
- CGLElectrode, Ion Based, Enzymatic, Creatinine2Product Code
- CGNAcid, Folic, Radioimmunoassay2Product Code
- CGOLieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol1Product Code
- CGRRadioimmunoassay, Cortisol2Product Code
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes2Product Code
- CGTRadioimmunoassay, Cyclic Gmp2Product Code
- CGXAlkaline Picrate, Colorimetry, Creatinine2Product Code
- CGZElectrode, Ion-Specific, Chloride2Product Code
- CHCTitrimetric Permanganate And Bromophenol Blue, Calcium2Product Code
- CHDAcid, Ferric Ion-Sulfuric, Cholesterol1Product Code
- CHERadioimmunoassay, Corticoids1Product Code
- CHGAcid, Phosphoric-Tungstic (Spectrophotometric), Chloride2Product Code
- CHHEnzymatic Esterase--Oxidase, Cholesterol1Product Code
- CHILipase-Esterase, Enzymatic, Photometric, Lipase1Product Code
- CHJMercuric Thiocyanate, Colorimetry, Chloride2Product Code
- CHKMercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride2Product Code
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph2Product Code
- CHMRadioimmunoassay, Total Estrogens In Pregnancy1Product Code
- CHORadioimmunoassay, Cyclic Amp2Product Code
- CHPRadioimmunoassay, Estradiol1Product Code
- CHQChromatographic/Fluorometric Method, Catecholamines1Product Code
- CHRTitrimetric Phenol Red, Carbon-Dioxide2Product Code
- CHSCoulometric Method, Carbon-Dioxide2Product Code
- CHTElectrophoretic Method, Catecholamines1Product Code
- CHWTitrimetric With Edta And Indicator, Calcium2Product Code
- CHZDi (O-Hydroxyphenylimine) Ethane, Calcium2Product Code
- CIAMethylthymol Blue, Calcium2Product Code
- CIBRadioimmunoassay, Angiotensin I And Renin2Product Code
- CICCresolphthalein Complexone, Calcium2Product Code
- CIDAlizarin Sulfonate, Calcium2Product Code
- CIEVolumetric/Manometric, Carbon-Dioxide2Product Code
- CIFVanillin Pyruvate, Ast/Sgot2Product Code
- CIGDiazo Colorimetry, Bilirubin2Product Code
- CIJSaccharogenic, Amylase2Product Code
- CIKRadial Diffusion, Amylase2Product Code
- CILCresol Red Colorimetry, Carbon-Dioxide2Product Code
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes2Product Code
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CIQDiazo, Ast/Sgot2Product Code
- CISHydrazone Colorimetry, Ast/Sgot2Product Code
- CITNadh Oxidation/Nad Reduction, Ast/Sgot2Product Code
- CIWStarch-Dye Bound Polymer, Amylase2Product Code
- CIXBromcresol Green Dye-Binding, Albumin2Product Code
- CIYRadioimmunoassay, Androsterone1Product Code
- CIZRadioimmunoassay, Androstenedione1Product Code
- CJAAmyloclastic, Amylase2Product Code
- CJBChromatographic Separation/Radioimmunoassay, Aldosterone2Product Code
- CJCFructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase1Product Code
- CJDNitrosalicylate Reduction, Amylase2Product Code
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJFTetrabromophenolphthalein, Albumin2Product Code
- CJGTetrabromo-M-Cresolsulfonphthalein, Albumin2Product Code
- CJHThymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJIDisodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJJDiazo, Alt/Sgpt1Product Code
- CJKPhenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJLBeta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJMRadioimmunoassay, Aldosterone2Product Code
- CJNAcid Phosphatase, Nitrophenylphosphate2Product Code
- CJOAlpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJQRadial Immunodiffusion, Albumin2Product Code
- CJRAcid Phosphatase, Thymol Blue Monophosphate2Product Code
- CJTHydrazone Colorimetry, Aldolase1Product Code
- CJWBromcresol Purple Dye-Binding, Albumin2Product Code
- CJXAcid Phosphatase, Disodium Phenylphosphate2Product Code
- CJYAzo Dye, Calcium2Product Code
- CJZAcid, Hydroxyazobenzene-Benzoic, Albumin2Product Code
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt1Product Code
- CKBAcid Phosphatase, Naphthyl Phosphate2Product Code
- CKCVanillin Pyruvate, Alt/Sgpt1Product Code
- CKDHydrazone Colorimetry, Alt/Sgpt1Product Code
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate2Product Code
- CKFPhenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CKGRadioimmunoassay, Acth2Product Code
- CKHAcid Phosphatase, Beta Glycerophosphate2Product Code
- DHASystem, Test, Human Chorionic Gonadotropin2Product Code
- GIMTubes, Vacuum Sample, With Anticoagulant2Product Code
- GJETray, Blood Collection2Product Code
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited2Product Code
- JFJCatalytic Methods, Amylase2Product Code
- JFLPh Rate Measurement, Carbon-Dioxide2Product Code
- JFMEnzymatic Method, Bilirubin2Product Code
- JFNAtomic Absorption, Calcium2Product Code
- JFOFluorometric, Calcium2Product Code
- JFPElectrode, Ion Specific, Calcium2Product Code
- JFSCoulometric, Chloride2Product Code
- JFTFluorometric, Cortisol2Product Code
- JFYEnzymatic Method, Creatinine2Product Code
- JGCTryptophan Measurement (Colorimetric), Globulin1Product Code
- JGDNephelometric Method, Globulin1Product Code
- JGETurbidimetric Method, Globulin1Product Code
- JGFDifferential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes2Product Code
- JGGL-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase1Product Code
- JGIAtomic Absorption, Magnesium1Product Code
- JGJPhotometric Method, Magnesium1Product Code
- JGKFerric Chloride, Phenylketones (Urinary, Non-Quant.)1Product Code
- JGMFlame Photometry, Potassium2Product Code
- JGPLowry (Colorimetric), Total Protein2Product Code
- JGQTurbidimetric, Total Protein2Product Code
- JGRRefractometric, Total Protein2Product Code
- JGSElectrode, Ion Specific, Sodium2Product Code
- JGTFlame Photometry, Sodium2Product Code
- JGWFluorometric Method, Triglycerides1Product Code
- JGXTurbidimetric Method, Triglycerides1Product Code
- JGYColorimetric Method, Triglycerides1Product Code
- JGZO-Phthalaldehyde, Urea Nitrogen2Product Code
- JHAAcid, Uric, Uricase (Gasometric)1Product Code
- JHCAcid, Uric, Uricase (Oxygen Rate)1Product Code
- JHDFluorometric Method, 17-Hydroxycorticosteroids1Product Code
- JHERadioassay, 17-Hydroxycorticosteroids1Product Code
- JHFColorimetric Method, Lecithin/Sphingomyelin Ratio2Product Code
- JHGChromatographic Separation, Lecithin/Sphingomyelin Ratio2Product Code
- JHHElectrophoretic Method, Lecithin/Sphingomyelin Ratio2Product Code
- JHIVisual, Pregnancy Hcg, Prescription Use2Product Code
- JHJAgglutination Method, Human Chorionic Gonadotropin2Product Code
- JHLMicrodensitometry Method, Lipoproteins1Product Code
- JHMColorimetric Method, Lipoproteins1Product Code
- JHNTurbidimetric Method, Lipoproteins1Product Code
- JHOElectrophoretic Separation, Lipoproteins1Product Code
- JHPRadial Immunodiffusion, Lipoproteins1Product Code
- JHQNephelometric Method, Lipoproteins1Product Code
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes2Product Code
- JHTChromatographic Separation, Cpk Isoenzymes2Product Code
- JHWU.V. Method, Cpk Isoenzymes2Product Code
- JHXFluorometric Method, Cpk Or Isoenzymes2Product Code
- JHYColorimetric Method, Cpk Or Isoenzymes2Product Code
- JIAEnzymatic Methods, Galactose1Product Code
- JIBU.V. Method, Galactose1Product Code
- JICColorimetric Method, Galactose1Product Code
- JIDPhotometric Method, Ammonia1Product Code
- JIEMethod, Ion-Exchange, Ammonia1Product Code
- JIFEnzymatic Method, Ammonia1Product Code
- JIGElectrode, Ion-Specific Method, Ammonia1Product Code
- JIJWet Ash Method, Protein-Bound Iodine1Product Code
- JIKDry Ash Method, Protein-Bound Iodine1Product Code
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)2Product Code
- JIMMethod, Metallic Reduction, Glucose (Urinary, Non-Quantitative)2Product Code
- JINNitroprusside, Ketones (Urinary, Non-Quant.)1Product Code
- JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)1Product Code
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)1Product Code
- JISCalibrator, Primary2Product Code
- JITCalibrator, Secondary2Product Code
- JIWCalibrator, Surrogate2Product Code
- JIXCalibrator, Multi-Analyte Mixture2Product Code
- JIYPhotometric Method, Iron (Non-Heme)1Product Code
- JIZAtomic Absorption, Iron (Non-Heme)1Product Code
- JJARadio-Labeled Iron Method, Iron (Non-Heme)1Product Code
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)1Product Code
- JJRElectrolyte Controls (Assayed And Unassayed)1Product Code
- JJSControls For Blood-Gases, (Assayed And Unassayed)1Product Code
- JJTEnzyme Controls (Assayed And Unassayed)1Product Code
- JJWUrinalysis Controls (Assayed And Unassayed)1Product Code
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1Product Code
- JJYMulti-Analyte Controls, All Kinds (Assayed)1Product Code
- JKATubes, Vials, Systems, Serum Separators, Blood Collection2Product Code
- JKBRadioimmunoassay, Compound S (11-Deoxycortisol)1Product Code
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)1Product Code
- JKDRadioimmunoassay, C-Peptides Of Proinsulin1Product Code
- JKFDinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge1Product Code
- JKGL-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase1Product Code
- JKHHydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen1Product Code
- JKJFluorometric Measurement, Porphyrins1Product Code
- JKLAcid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry1Product Code
- JKPChromium-51, Blood Volume1Product Code
- JKRRadioimmunoassay, Calcitonin2Product Code
- JKWN-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin1Product Code
- JKXN-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin1Product Code
- JKYOxalydihydrazide (Spectroscopic), Copper1Product Code
- JKZDiethyldithiocarbamate (Colorimetric), Copper1Product Code
- JLAConversion To Creatinine, Creatine1Product Code
- JLBAtp And Creatine Kinase (Enzymatic), Creatine1Product Code
- JLCNitroprusside Reaction (Qualitative, Urine), Cystine1Product Code
- JLDChromatographic, Cystine1Product Code
- JLERadioimmunoassay, Desoxycorticosterone1Product Code
- JLFRadioimmunoassay, Etiocholanolone1Product Code
- JLGConversion To Ferric Hydroxymates (Colorimetric), Fatty Acids1Product Code
- JLHTitrimetric, Fatty Acids1Product Code
- JLITetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid1Product Code
- JLJUridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate2Product Code
- JLKSodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity1Product Code
- JLLTubeless Analysis, Gastric Acidity1Product Code
- JLNChromatographic, Glutathione1Product Code
- JLOEnzymatic (Glutathione Reductase), Glutathione1Product Code
- JLPSpectrophotometric Method, Pregnanediol1Product Code
- JLQSpectrophotometric Method, Pregnanetriol1Product Code
- JLRGas Chromatography, Pregnanetriol1Product Code
- JLSRadioimmunoassay, Progesterone1Product Code
- JLTAcid, Pyruvic, Enzymatic (U.V.)1Product Code
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone2Product Code
- JLXRadioimmunoassay, 17-Hydroxyprogesterone1Product Code
- JLYPhosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid1Product Code
- JLZNadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid1Product Code
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)1Product Code
- JMDRadioimmunoassay, Total Estrogens, Nonpregnancy1Product Code
- JMERadioimmunoassay, Glucagon1Product Code
- JMFRadioimmunoassay, Human Placental Lactogen2Product Code
- JMIChromatographic, Histidine1Product Code
- JMJMicrobiological, Histidine1Product Code
- JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase1Product Code
- JMMColumn Chromatography & Color Development, Hydroxyproline1Product Code
- JMNExtraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline1Product Code
- JMOFerrozine (Colorimetric) Iron Binding Capacity1Product Code
- JMQM. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)1Product Code
- JMRImmunochemical, Lysozyme (Muramidase)1Product Code
- JMSAcid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase1Product Code
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)1Product Code
- JMW2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen)1Product Code
- JMXNinhydrin, Nitrogen (Amino-Nitrogen)1Product Code
- JMYCitrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase1Product Code
- JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality1Product Code
- JNAVapor Pressure, Osmolality Of Serum & Urine1Product Code
- JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine2Product Code
- JNCColumn Or Paper Chromatography Plus Ninhydrin, Phenylalanine2Product Code
- JNDNadp Reduction, 6-Phosphogluconate Dehydrogenase1Product Code
- JNEGlucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase1Product Code
- JNFIon-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen1Product Code
- JNGRadioimmunoassay, Pregnenolone1Product Code
- JNJPhosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase1Product Code
- JNKBeta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase1Product Code
- JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin1Product Code
- JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin1Product Code
- JNPInfrared Spectroscopy Measurement, Urinary Calculi (Stone)1Product Code
- JNQQualitative Chemical Reactions, Urinary Calculi (Stone)1Product Code
- JNSStannous Chloride - Hydrazine, Phospholipids1Product Code
- JNTChromatographic, Phospholipids1Product Code
- JNXMembrane Osmometry, Plasma Oncometry1Product Code
- JNYGlyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate Isomerase1Product Code
- JNZFluorometric, Uroporphyrin1Product Code
- JOAAcid, Trifluoroacetic, Vitamin A, Hexane Extraction1Product Code
- JOBHexane Extraction, Fluorescence, Vitamin E1Product Code
- JOCColorimetric, Xylose1Product Code
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase1Product Code
- JQAElectrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes1Product Code
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase1Product Code
- JQDResin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity1Product Code
- JQEResin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity1Product Code
- JQFBathophenanthroline, Iron Binding Capacity1Product Code
- JQGRadiometric, Fe59, Iron Binding Capacity1Product Code
- JQHTrinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen)1Product Code
- JQIRotating Disc, Plasma Viscometry1Product Code
- JQJDensitometeric, Protein Fractionation1Product Code
- JQKImmunodiffusion, Protein Fractionation1Product Code
- JQLSpectrophotometric, Uroporphyrin1Product Code
- JQMP-Bromoaniline, Xylose1Product Code
- JQNColorimetric, Mucopolysaccharides1Product Code
- KHMNephelometric, Amylase2Product Code
- KHPAcid, Lactic, Enzymatic Method1Product Code
- KHQRadioassay, Triiodothyronine Uptake2Product Code
- KHSEnzymatic, Carbon-Dioxide2Product Code
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine2Product Code
- KLJNad Reduction (U.V.), Phosphohexose Isomerase1Product Code
- KMSPhenolphthalein Colorimetry, Carbon-Dioxide2Product Code
- KNKAcid, Uric, Uricase (Colorimetric)1Product Code
- KQNRadioassay, Angiotensin Converting Enzyme2Product Code
- KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase2Product Code
- KWWRadioimmunoassay, Cholyglycine, Bile Acids2Product Code
- KWXRadioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids2Product Code
- LBRLdl & Vldl Precipitation, Hdl1Product Code
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1Product Code
- LBTElectrophoresis, Cholesterol Via Esterase-Oxidase, Hdl1Product Code
- LCHTonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical1Product Code
- LCXKit, Test, Pregnancy, Hcg, Over The Counter2Product Code
- LFPConductivity Rate, Urea Nitrogen2Product Code
- LFQAcid, Uric, Acid Reduction Of Ferric Ion1Product Code
- LFRGlucose Dehydrogenase, Glucose2Product Code
- LFSRadioreceptor Assay, Human Chorionic Gonadotropin2Product Code
- LIGRadioassay, Intrinsic Factor Blocking Antibody2Product Code
- LPSUrinary Homocystine (Nonquantitative) Test System2Product Code
- LPTSystem, Test, Urinary Methylmalonic Acid2Product Code
- LPWSystem, Test, Oxalate1Product Code
- MMIImmunoassay Method, Troponin Subunit2Product Code
- MPGUrinary Carbohydrate Analysis Kit1Product Code
- MQMBilirubin (Total And Unbound) In The Neonate Test System1Product Code
- MRGSystem, Test, Vitamin D2Product Code
- MRRSystem, Test, Low Density, Lipoprotein1Product Code
- MRVDrink, Glucose Tolerance2Product Code
- MSJApolipoproteins1Product Code
- MSMSystem, Test, Lipoprotein(A)1Product Code
- MYTBiosensor, Immunoassay, Cpk Or Isoenzymes2Product Code
- MZUSystem, Test, Sodium, Enzymatic Method2Product Code
- MZVTest, System, Potassium, Enzymatic Method2Product Code
- NAKSystem, Test, Biotinidase2Product Code
- NALTest, Immunoassay, Biosensor, Hcg2Product Code
- NAOTest, Carbohydrate Deficient Transferrin1Product Code
- NAQLipoprotein, High Density, Hdl, Over The Counter1Product Code
- NBCTest, Natriuretic Peptide2Product Code
- NBWSystem, Test, Blood Glucose, Over The Counter2Product Code
- K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System2Cleared 510(K)
- K243060TeleRPM Gen2 Blood Glucose Monitoring System2Cleared 510(K)
- K240637RIGHTEST Blood Glucose Monitoring System Max Tel2Cleared 510(K)
- K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System2Cleared 510(K)
- K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System2Cleared 510(K)
- K222126VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System2Cleared 510(K)
- K241304WaveSense Jazz Blood Glucose Monitoring System2Cleared 510(K)
- K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring System2Cleared 510(K)
- K231192RIGHTEST Blood Glucose Monitoring System Max Tel2Cleared 510(K)
- K233058VivaChek Link Plus Blood Glucose Monitoring System2Cleared 510(K)
- K231476TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System2Cleared 510(K)
- K230625ReliOn Premier BLU Blood Glucose Monitoring System2Cleared 510(K)
- K213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring system2Cleared 510(K)
- K223722MIO Blood Glucose Monitoring System2Cleared 510(K)
- K222234GlucoSure ADVANCE Link Blood Glucose Monitoring System2Cleared 510(K)
- K223293CONTOUR® NEXT GEN Blood Glucose Monitoring System2Cleared 510(K)
- K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System2Cleared 510(K)
- K213061SuperCheck Pro Blood Glucose Monitoring System2Cleared 510(K)
- K212248GlucoLeader Enhance 2 Blood Glucose Monitoring System2Cleared 510(K)
- K212140GlucoSure Link Blood Glucose Monitoring System2Cleared 510(K)
- K202739Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System2Cleared 510(K)
- K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System2Cleared 510(K)
- K203711IWL2020 Blood Glucose Monitoring System2Cleared 510(K)
- K202534MTM301 Blood Glucose and Ketone Monitoring System2Cleared 510(K)
- K213887GAL-1A Plus Blood Glucose Monitoring System2Cleared 510(K)
- K193406CardioChek Plus Test System; CardioChek Plus Home Test System2Cleared 510(K)
- K193407Contour® next GEN Blood Glucose Monitoring System2Cleared 510(K)
- K201880MultiSure GK Link Blood Glucose and Ketone Monitoring System2Cleared 510(K)
- K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System2Cleared 510(K)
- K202885GlucoSure HT Plus Blood Glucose Monitoring System2Cleared 510(K)
- K201258EASYMAX Tag Self-Monitoring Blood Glucose System2Cleared 510(K)
- K210687CONTOUR® NEXT ONE Blood Glucose Monitoring System2Cleared 510(K)
- K203562Finetest Lite Blood Glucose Monitoring System2Cleared 510(K)
- K201396Finetest Lite Smart Blood Glucose Monitoring System2Cleared 510(K)
- K193340GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System2Cleared 510(K)
- K200277Livongo Blood Glucose Monitoring System (BG1000)2Cleared 510(K)
- K191657Bioland Blood Glucose Monitoring System2Cleared 510(K)
- K193475OneTouch Verio Reflect Blood Glucose Monitoring System2Cleared 510(K)
- K192859CareSens S Clear BT Blood Glucose Monitoring System2Cleared 510(K)
- K193590CareSens S Fit BT Blood Glucose Monitoring System2Cleared 510(K)
- K192220ReliOn Premier Classic Blood Glucose Monitoring System2Cleared 510(K)
- K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System2Cleared 510(K)
- K190189MDT2 BLE Self-Monitoring Blood Glucose System2Cleared 510(K)
- K192175On Call Express II Blood Glucose Monitoring System2Cleared 510(K)
- K191038On Call Express Voice Blood Glucose Monitoring System2Cleared 510(K)
- K190579TD-4183 Blood Glucose Monitoring System2Cleared 510(K)
- K190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB2Cleared 510(K)
- K182428GlucoLeader Enhance Blood Glucose Monitoring System2Cleared 510(K)
- K183306GLUCOCARD® W onyx Blood Glucose Monitoring System2Cleared 510(K)
- K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)2Cleared 510(K)
- K173140VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System2Cleared 510(K)
- K181131Accu-Chek Guide Me Blood Glucose Monitoring System2Cleared 510(K)
- K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System2Cleared 510(K)
- K181588POPS! one Blood Glucose Monitoring System2Cleared 510(K)
- K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System2Cleared 510(K)
- K182992BGM014 Blood Glucose Monitoring System2Cleared 510(K)
- K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System2Cleared 510(K)
- K181527On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System2Cleared 510(K)
- K182286Oh'Care Lite Smart Blood Glucose Monitoring System2Cleared 510(K)
- K180866CareSens S Fit Blood Glucose Monitoring System2Cleared 510(K)
- K182057EasyMax BT Self-Monitoring Blood Glucose System2Cleared 510(K)
- K173658Confidence Blood Glucose Monitoring System2Cleared 510(K)
- K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus2Cleared 510(K)
- K173505FORA GTel Blood Glucose Monitoring System2Cleared 510(K)
- K173511ActiveCare TD-4121 Blood Glucose Monitoring System2Cleared 510(K)
- K173139Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus2Cleared 510(K)
- K181316POGO Automatic Blood Glucose Monitoring System2Cleared 510(K)
- K172723Dario LC Blood Glucose Monitoring System2Cleared 510(K)
- K180196On Call Express Mobile Blood Glucose Monitoring System2Cleared 510(K)
- K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System2Cleared 510(K)
- K170464StatStrip Xpress Blood Glucose Monitoring System2Cleared 510(K)
- K163087PixoTest Blood Glucose Monitoring System2Cleared 510(K)
- K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System2Cleared 510(K)
- K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System2Cleared 510(K)
- K170241GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System2Cleared 510(K)
- K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System2Cleared 510(K)
- K170264Gold AQ Blood Glucose Monitoring System2Cleared 510(K)
- K171941FreeStyle Precision Neo Blood Glucose Test Strips2Cleared 510(K)
- K171822NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)2Cleared 510(K)
- K171785WowGoHealth Blood Glucose Monitoring System2Cleared 510(K)
- K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)2Cleared 510(K)
- K170064GLUCOCARD W Blood Glucose Monitoring System2Cleared 510(K)
- K163159Dario Blood Glucose Monitoring System2Cleared 510(K)
- K170143GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,2Cleared 510(K)
- K162564Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System2Cleared 510(K)
- K161790iGlucose Blood Glucose Monitoring System2Cleared 510(K)
- K160179VivaChek Ino Blood Glucose Monitoring System2Cleared 510(K)
- K162382Smart Dongle Blood Glucose Monitoring System2Cleared 510(K)
- K162203POGO Automatic Blood Glucose Monitoring System2Cleared 510(K)
- K152534Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System2Cleared 510(K)
- K170267BGM009 Plus Blood Glucose Monitoring System2Cleared 510(K)
- K153561AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System2Cleared 510(K)
- K162430UniStrip1 Generic Blood Glucose Test Strips2Cleared 510(K)
- K162336Contour Next EZ Blood Glucose Monitoring System2Cleared 510(K)
- K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System2Cleared 510(K)
- K160742NoCoding1 Plus Blood Glucose Monitoring System2Cleared 510(K)
- K161834One Drop Blood Glucose Monitoring System2Cleared 510(K)
- K160682CONTOUR NEXT ONE Blood Glucose Monitoring System2Cleared 510(K)
- K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems2Cleared 510(K)
- K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System2Cleared 510(K)
- K160944ACCU-CHEK Guide Blood Glucose Monitoring System2Cleared 510(K)
- K153286iHealth Align Gluco-Monitoring system2Cleared 510(K)
- K153278Wireless Smart Gluco-Monitoring System2Cleared 510(K)
- K161867On Call Pro Blood Glucose Monitoring System2Cleared 510(K)
- K160038UniStrip1 Generic Blood Glucose Test Strips2Cleared 510(K)
- K152599PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System2Cleared 510(K)
- K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System2Cleared 510(K)
- K153201SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System2Cleared 510(K)
- K160156StatStrip Xpress Blood Glucose Monitoring System2Cleared 510(K)
- K152493POGO Automatic Blood Glucose Monitoring System2Cleared 510(K)
- K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System2Cleared 510(K)
- K143548TRUE METRIX GO Self Monitoring Blood Glucose System2Cleared 510(K)
- K153330FreeStyle Precision Neo H Blood Glucose Monitoring System2Cleared 510(K)
- K143169MyGlucoHealth Wireless System2Cleared 510(K)
- K150817Dario Blood Glucose Monitoring System2Cleared 510(K)
- K152442Freestyle Freedom Blood Glucose Monitoring Sytem2Cleared 510(K)
- K142785PRODIGY iConnect Blood Glucose Monitoring System2Cleared 510(K)
- K151611OneTouch Ultra Plus Flex Blood Glucose Monitoring System2Cleared 510(K)
- K150833iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System2Cleared 510(K)
- K151658Gmate Origin Blood Glucose Monitoring System2Cleared 510(K)
- K150942Contour Next USB Blood Glucose Monitoring System2Cleared 510(K)
- K151265SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System2Cleared 510(K)
- K150299Gmate SMART Blood Glucose Monitoring System2Cleared 510(K)
- K150396Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips2Cleared 510(K)
- K140325Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System2Cleared 510(K)
- K141656GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K142928FreeStyle Precision Neo Blood Glucose Monitoring System2Cleared 510(K)
- K151100U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System2Cleared 510(K)
- K151595On Call Express Pro Blood Glucose Monitoring System2Cleared 510(K)
- K150274GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System2Cleared 510(K)
- K151164Assure Prism multi Blood Glucose Monitoring System2Cleared 510(K)
- K132929SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K150214OneTouch Verio Flex Blood Glucose Monitoring System2Cleared 510(K)
- K141292Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System2Cleared 510(K)
- K150531FreeStyle Freedom Lite Blood Glucose Monitoring System2Cleared 510(K)
- K150332FreeStyle Lite Blood Glucose Monitoring System2Cleared 510(K)
- K143387GE333 Blood Glucose Monitoring System2Cleared 510(K)
- K140068CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM2Cleared 510(K)
- K141351SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K140150Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-302Cleared 510(K)
- K143467FORA GD43 Blood Glucose Monitoring System2Cleared 510(K)
- K141036BGM009 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K132663I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K141914PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K150052TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System2Cleared 510(K)
- K141867ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K141862HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE2Cleared 510(K)
- K140371FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)2Cleared 510(K)
- K141829GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K131173FIA Blood Glucose Monitoring System (G2)2Cleared 510(K)
- K142035GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K133741ACCU-CHEK Performa Blood Glucose Monitoring System2Cleared 510(K)
- K140210RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM7202Cleared 510(K)
- K132633OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K131230GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION2Cleared 510(K)
- K140100TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K140141LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K133260MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K132180IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K130265CONTOUR NEXT EZ BLOOD GLUCOSE METER2Cleared 510(K)
- K133790IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM2Cleared 510(K)
- K133862ACCU-CHEK AVIVA PLUS SYSTEM2Cleared 510(K)
- K132406ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K133522RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM2Cleared 510(K)
- K133389EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K133045ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K133647EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K133509EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO2Cleared 510(K)
- K123517GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K131469ACON ON CALL DIABETES MANAGEMENT SOFTWARE2Cleared 510(K)
- K132511FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM2Cleared 510(K)
- K130284ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K133346SMARTLOG DIABETES MANAGEMENT SOFTWARE2Cleared 510(K)
- K132086ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K132862HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K132966GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K122340PRODIGY CHOICE2Cleared 510(K)
- K132288CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER2Cleared 510(K)
- K123090GLB BENECHECK PREMIUM GLU MONITORING SYSTEM2Cleared 510(K)
- K132821AGAMATRIX HEALTH MANAGER2Cleared 510(K)
- K113135UNISTRIP 12Cleared 510(K)
- K122338PREFERRED BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K132338DA01 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K132272GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION2Cleared 510(K)
- K131013FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K122370CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR2Cleared 510(K)
- K131363ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K130244DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K130696CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K132072TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K122181EBCHEK BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K131419ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K131029ACCU-CHEK AVIVA PLUS TEST STRIP2Cleared 510(K)
- K130181GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K130621BROADMASTER HEALTHCARE SYSTEM2Cleared 510(K)
- K130657LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE2Cleared 510(K)
- K123559SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM2Cleared 510(K)
- K130094FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM2Cleared 510(K)
- K130295LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.2Cleared 510(K)
- K123007VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K123087TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K123016VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS2Cleared 510(K)
- K124040FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K122525SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K130886GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION2Cleared 510(K)
- K120989TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K130535IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION2Cleared 510(K)
- K123935IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K123089FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-0012Cleared 510(K)
- K122307DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM2Cleared 510(K)
- K123136GENESIS HEALTH RECORD SYSTEM, (GHRS)2Cleared 510(K)
- K113614ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K102751LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K120708ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K120558ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION2Cleared 510(K)
- K123008RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN2Cleared 510(K)
- K122142GLOOKO LOGBOOK CHARTS2Cleared 510(K)
- K123010ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K120866DA01 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K120813BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K103542GENSTRIP TEST STRIP MODEL 100-2012Cleared 510(K)
- K121679ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K120064TEST, BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K112916TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM2Cleared 510(K)
- K120423BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM6502Cleared 510(K)
- K113077BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K113192HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K121133CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K120649AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K121087CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K110074HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K120183ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K120351CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA2Cleared 510(K)
- K120568FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K110737RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM7002Cleared 510(K)
- K103329DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION2Cleared 510(K)
- K112638NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS2Cleared 510(K)
- K111456MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K103044AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION2Cleared 510(K)
- K113343DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K111890FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K102383MICRODOT & MICRODOT XTRA2Cleared 510(K)
- K110017AG-608N BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K113098AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III2Cleared 510(K)
- K100437AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION2Cleared 510(K)
- K113137GLUCOSE TEST SYSTEM2Cleared 510(K)
- K101926FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K112275FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K103544IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D2Cleared 510(K)
- K112963TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS2Cleared 510(K)
- K111932IGLUCOSE SYSTEM2Cleared 510(K)
- K111509SWEETSPOT DIABETES DATA MANAGEMENT SERVICE2Cleared 510(K)
- K103021ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K103115PRODIGY DIABETES MANAGEMENT SOFTWARE2Cleared 510(K)
- K102063HEALTH-E-CONNECT SYSTEM2Cleared 510(K)
- K112738ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE2Cleared 510(K)
- K103396COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION2Cleared 510(K)
- K110435EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K100806DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM2Cleared 510(K)
- K102816GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS2Cleared 510(K)
- K101631FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K101635TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K101543TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC2002Cleared 510(K)
- K102678ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS2Cleared 510(K)
- K101307BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-69512Cleared 510(K)
- K110571TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE2Cleared 510(K)
- K093755AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K111029FORA POCT MANAGMENT SYSTEM2Cleared 510(K)
- K101509U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K102345EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS100422Cleared 510(K)
- K102049CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K110709ARK CARE DIABETES MANAGMENT SYSTEM2Cleared 510(K)
- K110948HEALTH CARE SYSTEM SOFTWARE2Cleared 510(K)
- K102481AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP2Cleared 510(K)
- K093745ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K101371ON CALL PLUS DIABETES MONITORING SOFTWARE2Cleared 510(K)
- K100937PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE2Cleared 510(K)
- K101597WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.42Cleared 510(K)
- K092875ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER2Cleared 510(K)
- K093262AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K100732FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-42412Cleared 510(K)
- K101457EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS100312Cleared 510(K)
- K100322TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 42772Cleared 510(K)
- K092052RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM5502Cleared 510(K)
- K092638FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-232Cleared 510(K)
- K100398SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K093819ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)2Cleared 510(K)
- K091168GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-00252Cleared 510(K)
- K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System2Cleared 510(K)
- K100560EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 62772Cleared 510(K)
- K094005FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K093940ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-42762Cleared 510(K)
- K100701SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 62772Cleared 510(K)
- K091555MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K093930DIDGET WORLD REPORTS2Cleared 510(K)
- K093764SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K092902U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC2Cleared 510(K)
- K093592ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-32232Cleared 510(K)
- K093475BASESENS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K092894EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K093789INTOUCH DIABETES2Cleared 510(K)
- K093712FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K093635MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS2Cleared 510(K)
- K093005FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-42642Cleared 510(K)
- K090609OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K091765EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K091547NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS2Cleared 510(K)
- K093035FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-42442Cleared 510(K)
- K092099NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-42542Cleared 510(K)
- K082683SD CHECK GOLD2Cleared 510(K)
- K090628DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 70802Cleared 510(K)
- K090405LIPIDPRO SYSTEM2Cleared 510(K)
- K083273MICRODOT XTRA2Cleared 510(K)
- K091157GLUCO LAB AUTO CODING, MODEL IGM-00222Cleared 510(K)
- K091815SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 62682Cleared 510(K)
- K092887EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS090092Cleared 510(K)
- K090653POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K090712EOCENE SYSTEM2Cleared 510(K)
- K091898BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-42342Cleared 510(K)
- K091820CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM2Cleared 510(K)
- K091481EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K090332ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460012Cleared 510(K)
- K091229GLUCOMANAGER DATA MANAGEMENT SOFTWARE2Cleared 510(K)
- K091296POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-092Cleared 510(K)
- K090389AP-1000 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K090188U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-42222Cleared 510(K)
- K090404FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-42472Cleared 510(K)
- K090629EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS2Cleared 510(K)
- K090187FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-42412Cleared 510(K)
- K083628GLUCODR AUTO SYSTEM2Cleared 510(K)
- K090185CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K090057ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K090495TRUEBALANCE BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K090536FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-42472Cleared 510(K)
- K062187BETACHEK GLUCOSE TEST2Cleared 510(K)
- K083263SYMCARE DIABETES MANAGEMENT PROGRAM2Cleared 510(K)
- K082328GLUCODR PLUS SYSTEM, MODEL AGM-30002Cleared 510(K)
- K082201G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A2Cleared 510(K)
- K080853DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM2Cleared 510(K)
- K083468CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)2Cleared 510(K)
- K083265JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-033812Cleared 510(K)
- K081796EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM2Cleared 510(K)
- K083099EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS080082Cleared 510(K)
- K082521EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K081703MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS2Cleared 510(K)
- K082020ENVISION BLOOD GLUCOSE TEST SYSTEM2Cleared 510(K)
- K081715FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM2Cleared 510(K)
- K082169PRO GLUCOSE TEST STRIP2Cleared 510(K)
- K081975RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)2Cleared 510(K)
- K082513ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K080923CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB2Cleared 510(K)
- K082486GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE2Cleared 510(K)
- K082618ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4552Cleared 510(K)
- K081451RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM1002Cleared 510(K)
- K081450RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM1102Cleared 510(K)
- K080960PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS2Cleared 510(K)
- K081726TYSONBIO LINK HEALTH MANAGEMENT SYSTEM2Cleared 510(K)
- K080641TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-812Cleared 510(K)
- K080710TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-812Cleared 510(K)
- K081957U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K073030AG-605 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K081389ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K080538IDEAL LIFE POD (MODEL ILP 0001)2Cleared 510(K)
- K072854DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K080283IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K081144CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-42432Cleared 510(K)
- K081318ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM2Cleared 510(K)
- K080014CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K080501SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-42402Cleared 510(K)
- K073231ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K0729053TEST SUPREME GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K073492DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K073494CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING2Cleared 510(K)
- K073137GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E12Cleared 510(K)
- K073699MCT-DIABETES2Cleared 510(K)
- K072441EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K072369EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K073118PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K073119CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K072274MAJOR III BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K072054RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM3102Cleared 510(K)
- K073573WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K072784PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K070053EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R22Cleared 510(K)
- K071493CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-42252Cleared 510(K)
- K072543ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K072039ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F2Cleared 510(K)
- K072413MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K072489REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K071507PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS2Cleared 510(K)
- K063771GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K071393JAZZ BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K062377MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 1002Cleared 510(K)
- K070559POLYMAP PWR-08-032Cleared 510(K)
- K070524MICRODOT BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K070941CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.02Cleared 510(K)
- K070255NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,900022Cleared 510(K)
- K070585ACCU-CHEK PERFORMA SYSTEM2Cleared 510(K)
- K070239MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K062395ACCU-CHEK SMART PIX2Cleared 510(K)
- K070593TRACKRECORD DATA MANAGEMENT SOFTWARE2Cleared 510(K)
- K062538EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K070850FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K070641ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-32232Cleared 510(K)
- K070472CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-42302Cleared 510(K)
- K070088ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K062567RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K063026OK METER BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K070017PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS2Cleared 510(K)
- K063409LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-00672Cleared 510(K)
- K062800CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO2Cleared 510(K)
- K062555EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G2Cleared 510(K)
- K063068FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6311002Cleared 510(K)
- K062770COPILOT HEALTH MANAGEMENT SYSTEM2Cleared 510(K)
- K063212CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K062347ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K062434ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-015282Cleared 510(K)
- K061234GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K062829DIACHEX BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K062235EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST2Cleared 510(K)
- K062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 70802Cleared 510(K)
- K062195MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K060620ACCU-CHEK AVIVA TEST STRIPS2Cleared 510(K)
- K060793ELEMENT BLOOD GLUCOSE TEST SYSTEM2Cleared 510(K)
- K060467PRODIGY BLOOD GLUCOSE TEST SYSTEM2Cleared 510(K)
- K061181ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-42072Cleared 510(K)
- K053593PRODIGY2Cleared 510(K)
- K052818EZ SMART-168 GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K061328THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)2Cleared 510(K)
- K052469GLUCOPACK2Cleared 510(K)
- K061118ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K051651G4, MODEL IGM-00042Cleared 510(K)
- K060470ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 70802Cleared 510(K)
- K051839FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 110012Cleared 510(K)
- K053312EASYMATE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K053635MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K052762LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-00672Cleared 510(K)
- K053529ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K052208GLUCOSE PILOT2Cleared 510(K)
- K052343E-SAN BLUETOOTH CRADLE2Cleared 510(K)
- K052108SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-1002Cleared 510(K)
- K050985GLUCODR SUPERSENSOR SYSTEM2Cleared 510(K)
- K051514ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4600022Cleared 510(K)
- K051802FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K051936CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS2Cleared 510(K)
- K051854CLEVER CHEK TD-4225, MODEL TD-42252Cleared 510(K)
- K0502243TEST GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K051147SIDEKICK BLOOD GLUCOSE TEST SYSTEM2Cleared 510(K)
- K050500FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K043340EZ SMART2Cleared 510(K)
- K051213PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS2Cleared 510(K)
- K043543BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K042795CLEVER CHEK TD-32132Cleared 510(K)
- K042678RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K043311ASCENSIA ELITE DIABETES CARE SYSTEM2Cleared 510(K)
- K043158ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K042005ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-42222Cleared 510(K)
- K040848EZ SMART2Cleared 510(K)
- K041750PTS PANELS CHOL+GLU TEST PANEL2Cleared 510(K)
- K040678EUSURE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K041107TAIDOC CHECK2Cleared 510(K)
- K040603PARADIGM LINK BLOOD GLUCOSE METER2Cleared 510(K)
- K040814MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM2Cleared 510(K)
- K040670MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL2Cleared 510(K)
- K040628PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM2Cleared 510(K)
- K032657TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)2Cleared 510(K)
- K033845PRECISION XCEED DIABETES MONITORING SYSTEM2Cleared 510(K)
- K031260FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 160052Cleared 510(K)
- K032029BTG SMARTEST GLUCOSE TEST SYSTEM2Cleared 510(K)
- K032985GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K031501EASYGLUCO, MODEL IGM00022Cleared 510(K)
- K032552ACCU-CHEK ADVANTAGE SYSTEM2Cleared 510(K)
- K023279GLUCOLEADER VALUE2Cleared 510(K)
- K030703TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS2Cleared 510(K)
- K031843MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K023256PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO2Cleared 510(K)
- K024194ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS2Cleared 510(K)
- K024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL2Cleared 510(K)
- K023832SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K023219BECTON DICKINSON DIABETES SOFTWARE2Cleared 510(K)
- K023584ASCENSIA DEX 2 DIABETES CARE SYSTEM2Cleared 510(K)
- K022545GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 5550202Cleared 510(K)
- K022581BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K022724SURESTEP BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K022182MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K021819ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K022171ACCU-CHEK COMPACT SYSTEM2Cleared 510(K)
- K021827MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM2Cleared 510(K)
- K021513ACCU-CHEK ADVANTAGE MODULE2Cleared 510(K)
- K020866FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM2Cleared 510(K)
- K021448MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM2Cleared 510(K)
- K020210GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)2Cleared 510(K)
- K020208GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)2Cleared 510(K)
- K012975SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS2Cleared 510(K)
- K014167LIBERTY BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K014099BIOSCANNER PLUS2Cleared 510(K)
- K012324ACCU-CHEK ACTIVE TEST SYSTEM2Cleared 510(K)
- K012014MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K013203BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS2Cleared 510(K)
- K011240EVENCARE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K012205GLUCOMETER DEX TEST SENSOR2Cleared 510(K)
- K010039QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION2Cleared 510(K)
- K012210MODIFICATION TO ACCU-CHEK INFORM METER2Cleared 510(K)
- K011616INDUO BLOOD GLUCOSE METER2Cleared 510(K)
- K011738ACCU-CHEK ACTIVE SYSTEM2Cleared 510(K)
- K010553PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY2Cleared 510(K)
- K010403PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 5637002Cleared 510(K)
- NDREnzyme Immunoassay, Inhibin-A1Product Code
- NDYTest, Cystatin C2Product Code
- NEOSystem, Test, Osteocalcin2Product Code
- NHGEnzyme Immunoassay, Cortisol, Salivary2Product Code
- NJVTest, Albumin Cobalt Binding2Product Code
- NQLSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry2Product Code
- NQMImmunoassay For Detection Of Amniotic Fluid Protein(S).1Product Code
- NRHSystem, Breath Measurement1Product Code
- OAMImmunoassay, Insulin-Like Growth Factor Binding Protein-11Product Code
- OHQMulti-Analyte Controls Unassayed1Product Code
- OLDInternal Polymerase Chain Reaction Control, Not Assay Specific1Product Code
- ONDOsmolality Of Tears1Product Code
- OSXGalectin-3 In Vitro Diagnostic Assay2Product Code
- OYGSt2 Assay2Product Code
- OYJDna Specimen Collection, Saliva2Product Code
- PDJHemoglobin A1c Test System2Product Code
- PDSAmniotic Fluid Protein Immunoassay1Product Code
- PFQMmp-9 Test System1Product Code
- PIGAcute Kidney Injury Test System2Product Code
- PJCNewborn Screening Specimen Collection Paper2Product Code
- PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device2Product Code
- PJEBlood/Plasma Collection Device For Dna Testing2Product Code
- PJTContinuous Glucose Monitor Secondary Display2Product Code
- PKUInsulin Pump Secondary Display2Product Code
- PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)2Product Code
- PQTAlpha-L-Iduronidase (Idua) Newborn Screening Test System2Product Code
- PQUAlpha-D-Glucosidase (Gaa) Newborn Screening Test System2Product Code
- PQVß-Glucocerebrosidase (Gba) Newborn Screening Test System2Product Code
- PQWAlpha-D-Galactosidase A (Gla) Newborn Screening Test System2Product Code
- PRJCapillary Blood Collection Device For Alternative Site Collection2Product Code
- PSL25-Oh-Vitamin D Mass Spectrometry Test System2Product Code
- PTCUric Acid Test System For At Home Prescription Use1Product Code
- PYPLow-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test1Product Code
- PYVHospital Continuous Glucose Monitoring System2Product Code
- PZIPrescription Use Blood Glucose Meter For Near-Patient Testing2Product Code
- QBJIntegrated Continuous Glucose Monitoring System, Factory Calibrated2Product Code
- QCCInsulin Pump Therapy Adjustment Calculator For Healthcare Professionals2Product Code
- QCLAcid-Sphingomyelinase (Asm) Newborn Screening Test System2Product Code
- QCMß-Galactocerebrosidase (Galc) Newborn Screening Test System2Product Code
- QDHMenopause Test System2Product Code
- QDKIntegrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management2Product Code
- QDLIntegrated Continuous Glucose Monitoring System For Professional Retrospective Use2Product Code
- QEIBreast Milk Macronutrients Test System2Product Code
- QIIIntegrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use2Product Code
- QJEMuscular Dystrophy Newborn Screening Test2Product Code
- QJIInteroperable Automated Glycemic Controller2Product Code
- QJSInteroperable Automated Glycemic Controller, Insulin Suspend2Product Code
- QLGIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems2Product Code
- QMABlood Collection Device For Cell-Free Nucleic Acid2Product Code
- QQBPrognostic Test For Assessment Of Liver Related Disease Progression2Product Code
- OJQCardiac Allograft Gene Expression Profiling Test System2Product Code
- QRXContinuous Glucose Monitor Informed Insulin Dose Calculator2Product Code
- QZGMenstrual Blood Collection Device2Product Code
- SAFIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter2Product Code
- SBHIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter2Product Code
- SFOElectrode Measurement, Drain Effluent Ph2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
CareSens S Fit BT Blood Glucose Monitoring System
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K193590
- 510(k) Type
- Special
- Applicant
- I-Sens, Inc.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/17/2020
- Days to Decision
- 25 days
- Submission Type
- Statement