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
- K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test2Cleared 510(K)
- K251053Shinetell PlusTM Digital Early Pregnancy Test2Cleared 510(K)
- K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette2Cleared 510(K)
- K242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream2Cleared 510(K)
- K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream2Cleared 510(K)
- K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip2Cleared 510(K)
- K240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)2Cleared 510(K)
- K241978Shinetell Digital Pregnancy Test2Cleared 510(K)
- K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream2Cleared 510(K)
- K232715Distinct® Digital Pregnancy Test2Cleared 510(K)
- K233624HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx2Cleared 510(K)
- K234152ACESO Early Pregnancy Test2Cleared 510(K)
- K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream2Cleared 510(K)
- K240025Clearblue® Early Detection Pregnancy Test2Cleared 510(K)
- K232864EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II2Cleared 510(K)
- K230741Macro & Micro-Test HCG Pregnancy Test Midstream2Cleared 510(K)
- K230038MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)2Cleared 510(K)
- K222305MissLan™ Digital Pregnancy Rapid Test2Cleared 510(K)
- K213379Clearblue ® Early Pregnancy Test2Cleared 510(K)
- K212418hCG One Step Pregnancy Test2Cleared 510(K)
- K213808Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream2Cleared 510(K)
- K210341One Step Pregnancy Test2Cleared 510(K)
- K212447SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream2Cleared 510(K)
- K200913Clearblue® Early Digital Pregnancy Test2Cleared 510(K)
- K203246Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)2Cleared 510(K)
- K193318Distinct® Early Detection Pregnancy Test2Cleared 510(K)
- K200133hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream2Cleared 510(K)
- K193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream2Cleared 510(K)
- K192843INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream2Cleared 510(K)
- K192123HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream2Cleared 510(K)
- K182328VeriClear Digital Early Result Pregnancy Test2Cleared 510(K)
- K190705WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream2Cleared 510(K)
- K181551DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette2Cleared 510(K)
- K183097Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream2Cleared 510(K)
- K180771Acro HCG Pregnancy Rapid Test2Cleared 510(K)
- K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette2Cleared 510(K)
- K173229Preview Digital Pregnancy Test2Cleared 510(K)
- K172512ACRO HCG Pregnancy Rapid Test2Cleared 510(K)
- K171136LIA Pregnancy Test2Cleared 510(K)
- K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test2Cleared 510(K)
- K150063One Step hCG Pregnancy Test2Cleared 510(K)
- K150022Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream2Cleared 510(K)
- K132085ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM2Cleared 510(K)
- K131236UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP2Cleared 510(K)
- K123567FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST2Cleared 510(K)
- K123436FIRST RESPONSE EARLY RESULT PREGNANCY TEST2Cleared 510(K)
- K131931CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST2Cleared 510(K)
- K123703HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)2Cleared 510(K)
- K122907FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER2Cleared 510(K)
- K123050EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)2Cleared 510(K)
- K112449QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST2Cleared 510(K)
- K103487FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST2Cleared 510(K)
- K102760ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 701720012Cleared 510(K)
- K103574PREGNANCY ONE STEP RAPID TEST2Cleared 510(K)
- K110889IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)2Cleared 510(K)
- K110433CLEARBLUE EASY PREGNANCY TEST2Cleared 510(K)
- K081150RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST2Cleared 510(K)
- K083716FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)2Cleared 510(K)
- K071930ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C2Cleared 510(K)
- K062703ONE STEP HCG PREGNANCY TEST2Cleared 510(K)
- K062096KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST2Cleared 510(K)
- K070054FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST2Cleared 510(K)
- K053236DAVID PREGNANCY TEST (MIDSTREAM)2Cleared 510(K)
- K061769E.P.T. CERTAINTY 1-STEP PREGNANCY TEST2Cleared 510(K)
- K060825MULTI-USE ELECTRONIC PREGNANCY TEST2Cleared 510(K)
- K060128CLEARBLUE EASY DIGITAL PREGNANCY TEST2Cleared 510(K)
- K053452PURE-AID PREGNANCY TEST2Cleared 510(K)
- K053138MYSET PREGNANCY TEST2Cleared 510(K)
- K060019ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)2Cleared 510(K)
- K051963BE-CERTAIN PREGNANCY TEST2Cleared 510(K)
- K050305ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-22Cleared 510(K)
- K050546ACON +/- MIDSTREAM PREGNANCY TEST2Cleared 510(K)
- K050930E.P.T. CERTAINTY PREGNANCY TEST2Cleared 510(K)
- K043231PROOF POSITIVE ELECTRONIC PREGNANCY TEST2Cleared 510(K)
- K043443ONE STEP HCG URINE PREGNANCY TEST2Cleared 510(K)
- K040866FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST2Cleared 510(K)
- K042280FACT PLUS ONE-STEP PREGNANCY TEST KIT2Cleared 510(K)
- K042151ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST2Cleared 510(K)
- K041748AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)2Cleared 510(K)
- K041404CLEARBLUE EASY EASY READ PREGNANCY TEST2Cleared 510(K)
- K041273ONE-STEP PREGNANCY TEST2Cleared 510(K)
- K040341CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST2Cleared 510(K)
- K040329MODIFICATION TO E.P.T. PREGNANCY TEST2Cleared 510(K)
- K033658E.P.T. PREGNANCY TEST2Cleared 510(K)
- K033041ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP2Cleared 510(K)
- K032992UNIMARK HOME PREGNANCY TEST DEVICE2Cleared 510(K)
- K031798GOOD MORNING TEST2Cleared 510(K)
- K032939EPT CERTAINTY PREGNANCY TEST2Cleared 510(K)
- K032661ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)2Cleared 510(K)
- K032510ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST2Cleared 510(K)
- K032159CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY2Cleared 510(K)
- K031271ONE-STEP PREGNANCY TEST2Cleared 510(K)
- K030659CLEARBLUE EASY DIGITAL PREGNANCY TEST2Cleared 510(K)
- K030533ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST2Cleared 510(K)
- K023037MID STREAM PREGNANCY TEST2Cleared 510(K)
- K030258FIRST RESPONSE PREGNANCY TEST2Cleared 510(K)
- K023638CASSETTE/URINE HCG2Cleared 510(K)
- K023027PREG-Q EARLY PREGNANCY TEST2Cleared 510(K)
- K023699CLEARBLUE EASY EARLY RESULT PREGNANCY TEST2Cleared 510(K)
- K023126AMEDITECH IMMUTEST HCG PREGANCY TEST2Cleared 510(K)
- K013907INVERNESS MEDICAL EARLY PREGNANCY TEST2Cleared 510(K)
- K013372CLEARBLUE EASY EARLY RESULT PREGNANCY TEST2Cleared 510(K)
- K011551SURE CHECK PREGNANCY TEST2Cleared 510(K)
- K012215QUIK-CHECK HOME PREGNANCY TEST2Cleared 510(K)
- K002049INVERNESS MEDICAL EARLY PREGNANCY TEST2Cleared 510(K)
- K993483ACON ONE STEP HOME PREGNANCY TEST STRIP2Cleared 510(K)
- K992232FIRST RESPONSE 1-STEP PREGNANCY2Cleared 510(K)
- K993333CLEARPLAN EASY II HOME PREGNANCY TEST2Cleared 510(K)
- K993141AT HOME QUICKCUP PREGNANCY TEST, MODEL 90152Cleared 510(K)
- K991369ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY2Cleared 510(K)
- K991193SAS HCG-CHECK2Cleared 510(K)
- K990262CLEARPLAN EASY HOME PREGNANCY TEST2Cleared 510(K)
- K990576OSOM CARD PREGNANCY TEST, MODEL 1032Cleared 510(K)
- K990373FACT PLUS ONE STEP PREGNANCY TEST2Cleared 510(K)
- K984075INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST2Cleared 510(K)
- K983090ACON MIDSTREAM PREGNANCY TEST2Cleared 510(K)
- K981892QUICK & SURE ONESTEP HOME PREGNANCY TEST2Cleared 510(K)
- K981722QUIDEL HOME PREGNANCY TEST2Cleared 510(K)
- K974059ONE STEP MIDSTREAM HCG PREGNANCY TEST2Cleared 510(K)
- K980532QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 90122Cleared 510(K)
- K974821BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST2Cleared 510(K)
- K974154CHOICE ACCU-TEST PREGNANCY TEST KIT2Cleared 510(K)
- K974021SIGNAL PREGNANCY TEST KIT2Cleared 510(K)
- K973570QUICK CARD HCG ONE STEP PREGNANCY TEST2Cleared 510(K)
- K973352BRAND NAME *1-STEP PREGNANCY2Cleared 510(K)
- K973208FIRST SIGN2Cleared 510(K)
- K972682QUICKSTICK ONE STEP HCG PREGNANCY TEST2Cleared 510(K)
- K971286EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST2Cleared 510(K)
- K970425EZ SURE URINE DIPSTICK PREGNANCY HOME TEST2Cleared 510(K)
- K970008ADVANCED QUALITY PREGNANCY TEST2Cleared 510(K)
- K965184PERFECTA PREGNANCY TEST2Cleared 510(K)
- K970082ABBOTT ADVISOR ONE-STEP PREGNANCY TEST2Cleared 510(K)
- K963341MIDSTREAM ONESTEP PREGNANCY HOME TEST2Cleared 510(K)
- K964108FACT PLUS PREGNANCY TEST2Cleared 510(K)
- K964002NATURALE HCG PREGNANCY TES2Cleared 510(K)
- K962721EVIDENCE PREGNANCY TEST2Cleared 510(K)
- K962888AFFIRM ONE-STEP HOME PREGNANCY TEST2Cleared 510(K)
- K962580EZ SURE ONESTEP EARLY PREGNANCY TEST2Cleared 510(K)
- K962521FACTPLUS ONE STEP PREGNANCY TEST2Cleared 510(K)
- K962219QUICKSTICK ONE STEP PREGNANCY TEST(9010)2Cleared 510(K)
- K962183BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES2Cleared 510(K)
- K961965SURE CHECK PREGNANCY TEST2Cleared 510(K)
- K961712TBD AT-HOME PREGNANCY TEST2Cleared 510(K)
- K960733MINISTICK PREGNANCY TEST2Cleared 510(K)
- K960316CLEARBLUE EASY2Cleared 510(K)
- K960174UNIMARK MIDSTREAM PREGNANCY TEST STICK2Cleared 510(K)
- K953606BEST PREGNANCY TEST2Cleared 510(K)
- K960436SELFCARE EARLY PREGNANCY TEST2Cleared 510(K)
- K960117PLATFORM ONESTEP PREGNANCY HOME TEST2Cleared 510(K)
- K955903SELFCARE EARLY PREGNANCY TEST2Cleared 510(K)
- K954178OSOM PREGNANCY TEST2Cleared 510(K)
- K954364CAMEO HOME PREGNANCY TEST2Cleared 510(K)
- K950354HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY2Cleared 510(K)
- K945514LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG2Cleared 510(K)
- K945846ADVANCE(R) PREGNANCY TEST2Cleared 510(K)
- K945568HCG MIDSTREAM PREGNANCY TEST2Cleared 510(K)
- K941765HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE2Cleared 510(K)
- K941771BODYWISE PREGNANCEY TEST2Cleared 510(K)
- K941355PREGNANCY CHECK2Cleared 510(K)
- K940637PREDICTOR HOME PREGNANCY TEST2Cleared 510(K)
- K933794ANI BIOCARD(TM) HCG TEST2Cleared 510(K)
- K936013EVATEST STRIP2Cleared 510(K)
- K934516ADVANCE PREGNANCY TEST MODIFICATION2Cleared 510(K)
- K934830HCG PREGNANCY ONE STEP TEST STRIP2Cleared 510(K)
- K931997HCG MIDSTREAM PREGNANCY TEST2Cleared 510(K)
- K930488BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST2Cleared 510(K)
- K930640PRECISE PREGNANCY2Cleared 510(K)
- K926308LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST2Cleared 510(K)
- K925189PREGNAGEN 1-STEP PREGNANCY TEST2Cleared 510(K)
- K925096CONCEIVE ONE-STEP PREGNANCY TEST2Cleared 510(K)
- K921099SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST2Cleared 510(K)
- K921012PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG2Cleared 510(K)
- K914990ADVANCE(R) PREGNANCY TEST2Cleared 510(K)
- K914304FIRST RESPONSE(R) ONE-STEP2Cleared 510(K)
- K914254HOMECLINIC ONE STEP PREGNANCY TEST2Cleared 510(K)
- K912316QUIKPAC-II ONE STEP PREGNANCY HOME TEST2Cleared 510(K)
- K911566CLEARBLUE EASY2Cleared 510(K)
- K905742CLEARBLUE EASY2Cleared 510(K)
- K904782ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST2Cleared 510(K)
- K901981ABBOTT MODIFIED FACT PLUS PREGNANCY TEST2Cleared 510(K)
- K896482PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT2Cleared 510(K)
- K895560MODIFIED HOMECLINIC PREGNANCY TEST2Cleared 510(K)
- K884489C&T PREGNANCY TEST KIT2Cleared 510(K)
- K883430PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST2Cleared 510(K)
- K883826HOME CLINIC PREGNANCY TEST2Cleared 510(K)
- K882232DISCOVER(R)2Cleared 510(K)
- K882588BLUE DOT(TM) TEST FOR PREGNANCY2Cleared 510(K)
- K882416CLEARBLUE EASY2Cleared 510(K)
- K880472ADVANCE* AND DAISY* PREGNANCY TEST2Cleared 510(K)
- K874823FIRST RESPONSE 5 MINUTE PREGNANCY TEST2Cleared 510(K)
- K880069LEECO PREGNASTICK (EIA) CATALOG #0032Cleared 510(K)
- K874248SYNTRON BIORESEARCH U-TEST PREGNANCY TEST2Cleared 510(K)
- K871601ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST2Cleared 510(K)
- K871996ABBOTT BIOTELL PREGNANCY TEST2Cleared 510(K)
- K863341CARDS(TM) - EARLY PREGNANCY TEST2Cleared 510(K)
- K864373CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)2Cleared 510(K)
- K863999VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-0422Cleared 510(K)
- K863841TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE2Cleared 510(K)
- K862207QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)2Cleared 510(K)
- K861946PTK PLUS. HOME PREGNANCY TEST2Cleared 510(K)
- K861168CLEARBLUE PREGNANCY TESTING KIT2Cleared 510(K)
- K860451MUREX (TM), SUDS (TM), HCG ASSAY2Cleared 510(K)
- K860090ANSWER PLUS AT HOME PREGNANCY TEST2Cleared 510(K)
- K853269PREGNA/TEST2Cleared 510(K)
- K852274ANSWER2Cleared 510(K)
- K850079NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG2Cleared 510(K)
- K844281PTK HEALTHCHECK PREGNANCY TEST KIT2Cleared 510(K)
- K834474H.P.T. HOME PREG. TEST KIT & A.P.T.2Cleared 510(K)
- K843238ANSWER ONE-DAY2Cleared 510(K)
- K842265ORTHO BRAND HOME PREGNANCY TEST2Cleared 510(K)
- K841415BETA STICK, PREGNANCY TEST2Cleared 510(K)
- K841595HEALTHCHECK HOME PREGNANCY TEST KIT2Cleared 510(K)
- K841602ACCURATE BETA 30 PREGNANCY TEST KIT2Cleared 510(K)
- K834270ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST2Cleared 510(K)
- K840602VERIFY PREGNANCY TEST KIT2Cleared 510(K)
- K832905QUALITATIVE ENZYME IMMUNOASSAY-DETECT2Cleared 510(K)
- K832593HOSPITAL LAB IN-HOME EARLY PREG TEST2Cleared 510(K)
- K833466EARLY PREGNANCY DETECTION TEST KIT2Cleared 510(K)
- K831108HOME PREGNANCY TEST KIT2Cleared 510(K)
- K831051HOME PREGNANCY TEST KIT HPK #12Cleared 510(K)
- K823109GENERIC PREGNANCY TEST2Cleared 510(K)
- K822449TPK 1980/12Cleared 510(K)
- K813272A-1 IN-HOME PREGNANCY TEST2Cleared 510(K)
- K780321PREGNANCY TEST KIT, OVER-THE-COUNTER2Cleared 510(K)
- K780240PREDICTOR2Cleared 510(K)
- K772359PREGNANCY TEST KIT, ANSWER2Cleared 510(K)
- 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
- 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
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- PTCUric Acid Test System For At Home Prescription Use1Product Code
- PYPLow-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test1Product Code
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- QCLAcid-Sphingomyelinase (Asm) Newborn Screening Test System2Product Code
- QCMß-Galactocerebrosidase (Galc) Newborn Screening Test System2Product Code
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- QDLIntegrated Continuous Glucose Monitoring System For Professional Retrospective Use2Product Code
- QEIBreast Milk Macronutrients Test System2Product Code
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- QJSInteroperable Automated Glycemic Controller, Insulin Suspend2Product Code
- QLGIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems2Product Code
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- 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
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- 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
One Step Pregnancy Test
- Page Type
- Cleared 510(K)
- 510(k) Number
- K210341
- 510(k) Type
- Traditional
- Applicant
- SPD Swiss Precision Diagnostics GmbH
- Country
- Switzerland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/10/2022
- Days to Decision
- 398 days
- Submission Type
- Summary