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
- K170678Beta-CrossLaps CalCheck 51Cleared 510(K)
- K162173Elecsys CYFRA 21-1 CalCheck 51Cleared 510(K)
- K162514Multichem A1c1Cleared 510(K)
- K161874Audit MicroControls Linearity DROP LQ Blood Glucose1Cleared 510(K)
- K161526LIAISON CMV IgM Serum Control Set1Cleared 510(K)
- K161522LIAISON EBV IgM Serum Control Set1Cleared 510(K)
- K161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers1Cleared 510(K)
- K152117Dropper hsCRP High Sensitivity CRP Control1Cleared 510(K)
- K151742Contour Next Control Solution1Cleared 510(K)
- K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material1Cleared 510(K)
- K150955Elecsys Progesterone III Cal Check 51Cleared 510(K)
- K150132IMMULITE IGF Control Module, IMMULITE Gastrin Control Module1Cleared 510(K)
- K143324IDS-iSYS CTX-I Calibration Verifiers1Cleared 510(K)
- K143373IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material1Cleared 510(K)
- K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material1Cleared 510(K)
- K143680ADVIA Centaur IgE Master Curve Material1Cleared 510(K)
- K143639IMMULITE 2000 CEA Calibration Verification Material1Cleared 510(K)
- K143571Audit MicroControls Linearity LQ Cystatin-C1Cleared 510(K)
- K143504IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material1Cleared 510(K)
- K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material1Cleared 510(K)
- K143376ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material1Cleared 510(K)
- K143296AIA-PACK C-Peptide Control Set1Cleared 510(K)
- K143284Elecsys Estradiol III Calcheck1Cleared 510(K)
- K143194ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)1Cleared 510(K)
- K143026Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity1Cleared 510(K)
- K142878IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material1Cleared 510(K)
- K142864ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)1Cleared 510(K)
- K142811IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)1Cleared 510(K)
- K142127ELECSYS ESTRADIOL III CALCHECK 51Cleared 510(K)
- K141772IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL1Cleared 510(K)
- K141444IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL1Cleared 510(K)
- K133816IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL1Cleared 510(K)
- K140818IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C1Cleared 510(K)
- K140541IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C1Cleared 510(K)
- K140505ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL1Cleared 510(K)
- K140534ELECSYS PRECICONTROL TS1Cleared 510(K)
- K140267ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)1Cleared 510(K)
- K140258IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL1Cleared 510(K)
- K133550VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT1Cleared 510(K)
- K133197FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE1Cleared 510(K)
- K132739IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL1Cleared 510(K)
- K133284ELECSYS CK-MB CALCHECK 51Cleared 510(K)
- K133122IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)1Cleared 510(K)
- K133124IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA1Cleared 510(K)
- K133003RIGHTEST CONTROL SOLUTION1Cleared 510(K)
- K133128IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION1Cleared 510(K)
- K131662IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL1Cleared 510(K)
- K132391IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL1Cleared 510(K)
- K131536IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL1Cleared 510(K)
- K131999HBA1C CONTROL, LEVEL 1 AND LEVEL 21Cleared 510(K)
- K131776ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 31Cleared 510(K)
- K123127VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 4061Cleared 510(K)
- K131136GLUCOSE METER-CHECK SOLUTION FOR TAIDOC1Cleared 510(K)
- K130764AUDIT MICROCV VITAMIN D LINEARITY SET1Cleared 510(K)
- K130157AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET1Cleared 510(K)
- K122534IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL1Cleared 510(K)
- K123851GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK1Cleared 510(K)
- K123966GLUCOSE METER-CHECK SOLUTION FOR BAYER1Cleared 510(K)
- K123612FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA1Cleared 510(K)
- K123798LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK1Cleared 510(K)
- K122242ELECSYS CA 15-3 II CALCHECK 51Cleared 510(K)
- K121895ELECSYS HSV-2 IGG IMMUNOASSAY1Cleared 510(K)
- K122141IDS-ISYS IGF-I CALIBRATION VERIFIERS1Cleared 510(K)
- K121746RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)1Cleared 510(K)
- K121588RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 31Cleared 510(K)
- K121534CONE-TROL HEMOGLOBIN A1C CONTROL SET1Cleared 510(K)
- K121237BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE1Cleared 510(K)
- K121279ELECSYS LH CALCHECK 51Cleared 510(K)
- K113177COMPLETE D 25-OH VITAMIN D CONTROL1Cleared 510(K)
- K121084LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L1Cleared 510(K)
- K112653ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS1Cleared 510(K)
- K111938IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...1Cleared 510(K)
- K112143AUDIT MICROCV T-UPTAKE LINEARITY1Cleared 510(K)
- K113764GLUCOSE METER-CHECK SOLUTION FOR INFOPIA1Cleared 510(K)
- K113524VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT1Cleared 510(K)
- K112352GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT1Cleared 510(K)
- K112603ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS1Cleared 510(K)
- K112528ELECSYS T4 CALCHECK 51Cleared 510(K)
- K110061CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL1Cleared 510(K)
- K112356GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE1Cleared 510(K)
- K112113ELECSYS MYOGLOBIN CALCHECK 51Cleared 510(K)
- K111650IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...1Cleared 510(K)
- K112104ELECSYS N-MID OSTEOCALCIN CALCHECK 51Cleared 510(K)
- K111552ELECSYS T3 CALCHECK 51Cleared 510(K)
- K111349ELECSYS SHBG CALCHECK 51Cleared 510(K)
- K110641FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL1Cleared 510(K)
- K110613ELECSYS PROLACTIN II CALCHECK 51Cleared 510(K)
- K103744DROPPER A1C DIABETES CONTROL1Cleared 510(K)
- K103683IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)1Cleared 510(K)
- K110436FDI GLUCOSE CONTROL SOLUTION FOR AVIVA1Cleared 510(K)
- K110412IDS-ISYS IFG-I CONTROL SET1Cleared 510(K)
- K103553LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION1Cleared 510(K)
- K103450FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE1Cleared 510(K)
- K103402ELECSYS DHEA-S CALCHECK 51Cleared 510(K)
- K101427AUDIT MICROCV HS-CRP LINEARITY SET1Cleared 510(K)
- K100715AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-51Cleared 510(K)
- K103099PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH1Cleared 510(K)
- K102904ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL1Cleared 510(K)
- K103162ELECSYS PTH CALCHECK 51Cleared 510(K)
- K102086ELECSYS CA 125 II CALCHECK 51Cleared 510(K)
- K102269ELECSYS IGE CALCHECK 51Cleared 510(K)
- K101856ELECSYS CEA CALCHECK 51Cleared 510(K)
- K101365ELECSYS CA 19-9 CALCHECK 51Cleared 510(K)
- K102260FDI GLUCOSE CONTROL SOLUTIONS1Cleared 510(K)
- K102267ELECSYS FERRITIN CALCHECK 51Cleared 510(K)
- K102044ELECSYS DIGOXIN CALCHECK 51Cleared 510(K)
- K093724FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION1Cleared 510(K)
- K101075ELECSYS INSULIN CALCHECK 51Cleared 510(K)
- K100750AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-51Cleared 510(K)
- K094031ELECSYS FOLATE III CALCHECK 51Cleared 510(K)
- K100810ELECSYS C-PEPTIDE CALCHECK 51Cleared 510(K)
- K092911SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER1Cleared 510(K)
- K093836ELECSYS TSH CALCHECK 51Cleared 510(K)
- K100747CONTREX PLUS LOW CONTROL SOLUTION1Cleared 510(K)
- K100594ELECSYS TROPONIN I CALCHECK 51Cleared 510(K)
- K093582ELECSYS CK-MB CALCHECK 51Cleared 510(K)
- K092848ELECSYS TROPONIN T CALCHECK 51Cleared 510(K)
- K093700ELECSYS HCG STAT CALCHECK 51Cleared 510(K)
- K092169ELECSYS PROBNP II CALCHECK 51Cleared 510(K)
- K093498LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 3109131Cleared 510(K)
- K092749MAS AND MINI-TROL PTH CONTROL1Cleared 510(K)
- K092993ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL1Cleared 510(K)
- K092168ELECSYS HCG+B CALCHECK 51Cleared 510(K)
- K092888ELECSYS TOXO IGG CALCHECK 51Cleared 510(K)
- K091914OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION1Cleared 510(K)
- K092585ELECSYS RUBELLA IGGA CALCHECK 51Cleared 510(K)
- K091601ELECYS ANTI-CCP CALCHECK1Cleared 510(K)
- K090104LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 3106031Cleared 510(K)
- K092645FDI GLUCOSE CONTROL LEVELS 1, 2 AND 31Cleared 510(K)
- K091123ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS1Cleared 510(K)
- K091460ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 21200871Cleared 510(K)
- K090943ABT GLUCOSE CONTROL SOLUTION, MODEL: 21200891Cleared 510(K)
- K090311ELECSYS RUBELLA IGG CALCHECK1Cleared 510(K)
- K090854ABT GLUCOSE CONTROL SOLUTION, MODEL 21200901Cleared 510(K)
- K083655ELECSYS TOXO IGG CALCHECK1Cleared 510(K)
- K083549ABT GLUCOSE CONTROL SOLUTION1Cleared 510(K)
- K081478RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS1Cleared 510(K)
- K082395GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC0021Cleared 510(K)
- K080643ELECSYS ANTI-TSHR CALCHECK1Cleared 510(K)
- K081915FDTX GLUCOSE CONTROL SOLUTION1Cleared 510(K)
- K080273AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION1Cleared 510(K)
- K081403GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK1Cleared 510(K)
- K080147ELECSYS PROBNP II CALCHECK1Cleared 510(K)
- K071648EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS1Cleared 510(K)
- K071587ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY1Cleared 510(K)
- K070506SMS MULTI GLUCOSE CONTROL, MODEL 21200491Cleared 510(K)
- K070649SMS GLUCOSE CONTROL, MODEL 21200611Cleared 510(K)
- K062957FASTPACK TOTAL PSA METHOD VERIFICATION KIT1Cleared 510(K)
- K063855LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 21200471Cleared 510(K)
- K062972PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS1Cleared 510(K)
- K062501VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 9011Cleared 510(K)
- K060510DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT1Cleared 510(K)
- K060706LIBERTY NORMAL GLUCOSE CONTROL SOLUTION1Cleared 510(K)
- K060570HEMOGLOBIN ALC CONTROL1Cleared 510(K)
- K060215ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.0021Cleared 510(K)
- K060481LIBERTY GLUCOSE CONTROL SOLUTION1Cleared 510(K)
- K060426LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 21200411Cleared 510(K)
- K060133ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET1Cleared 510(K)
- K060027ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)1Cleared 510(K)
- K053327OXICOM CONTROL1Cleared 510(K)
- K052980LIBERTY GLUCOSE CONTROL, MODEL 21200311Cleared 510(K)
- K053059ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK1Cleared 510(K)
- K052679CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E1Cleared 510(K)
- K052010HBA1C LINEARITY SET1Cleared 510(K)
- K050983IRMA TRUPOINT CREATININE CONTROL KIT1Cleared 510(K)
- K050961RNA1C CONTROL FOR NYCOCARD HBA1C1Cleared 510(K)
- K050328PREGNANCY-SKREEN1Cleared 510(K)
- K050100RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER1Cleared 510(K)
- K043584LIQUICHEK BNP CONTROL1Cleared 510(K)
- K043320MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II1Cleared 510(K)
- K043070LIQUID STABLE HBA1C CONTROL1Cleared 510(K)
- K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL1Cleared 510(K)
- K042837LIQUICHEK ELEVATED CRP CONTROL1Cleared 510(K)
- K042448DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT1Cleared 510(K)
- K042303VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS1Cleared 510(K)
- K042080TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM1Cleared 510(K)
- K041687ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR1Cleared 510(K)
- K041898CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM1Cleared 510(K)
- K041871INTERLAB MICROCAL SERUM CONTROLS1Cleared 510(K)
- K041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H1Cleared 510(K)
- K040927LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS1Cleared 510(K)
- K040918WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 21Cleared 510(K)
- K041016NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS1Cleared 510(K)
- K040351RANDOX LIQUID CRP CONTROLS1Cleared 510(K)
- K034048R&D GLU-LINE HEMATOLOGY CONTROL1Cleared 510(K)
- K040455LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS1Cleared 510(K)
- K040025A1C-CELLULAR1Cleared 510(K)
- K040157ELECSYS C-PEPTIDE CALCHECK1Cleared 510(K)
- K030849AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT11Cleared 510(K)
- K033433NOVA GLUCOSE CONTROL SOLUTIONS1Cleared 510(K)
- K033127VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS1Cleared 510(K)
- K032993VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS1Cleared 510(K)
- K032819GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM1Cleared 510(K)
- K031873I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET1Cleared 510(K)
- K031990ELECSYS PRECICONTROL TROPONIN T1Cleared 510(K)
- K031698ELECYS SHBG CALCHECK1Cleared 510(K)
- K031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL1Cleared 510(K)
- K030628SAS RSV CONTROL KIT1Cleared 510(K)
- K030065WAKO NEFA LINEARITY SET1Cleared 510(K)
- K020883ELECSYS PROBNP CALCHECK1Cleared 510(K)
- K022769LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION1Cleared 510(K)
- K023307MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL1Cleared 510(K)
- K022725CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 30131Cleared 510(K)
- K022758LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER1Cleared 510(K)
- K022491LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS1Cleared 510(K)
- K022232CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 31Cleared 510(K)
- K021697GLUCOSE CONTROL SOLUTION FOR BD LATITUDE1Cleared 510(K)
- K021624RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL41Cleared 510(K)
- K020217ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY1Cleared 510(K)
- K020369ELECSYS ANTI-TG CALCHECK1Cleared 510(K)
- K013900VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS1Cleared 510(K)
- K013119VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 100061Cleared 510(K)
- K013147GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE1Cleared 510(K)
- K013130N LP(A) CONTROL SY1Cleared 510(K)
- K012561VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS1Cleared 510(K)
- K012430MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL31Cleared 510(K)
- K012122VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 100051Cleared 510(K)
- K011463VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS1Cleared 510(K)
- K011250VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS1Cleared 510(K)
- K010693VIGIL DNASE B CONTROL1Cleared 510(K)
- K010428ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #333491Cleared 510(K)
- K010237ELECSYS HCG+B CALCHECK1Cleared 510(K)
- K003967CA 125 II CALCHECK1Cleared 510(K)
- K003772ELECSYS DHEA-S CALCHECK1Cleared 510(K)
- K003095FASTPACK CONTROL1Cleared 510(K)
- K001651BIO-RAD %CDT TIA1Cleared 510(K)
- K003112VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS1Cleared 510(K)
- K002540BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS1Cleared 510(K)
- K001443SUGAR CHEX ONE1Cleared 510(K)
- K001846ELECSYS INSULIN CALCHECK1Cleared 510(K)
- K001458SYNCHRON CONTROL1Cleared 510(K)
- K001014ELECSYS ANTI-TPO CALCHECK1Cleared 510(K)
- K001015ELECSYS THYROGLOBULIN CALCHECK1Cleared 510(K)
- K992781ARCHITECH AFP MASTERCHECK, MODEL 6C01-051Cleared 510(K)
- K000042ELECSYS B-CROSSLAPS CALCHECK1Cleared 510(K)
- K000231TRIAGE BNP CALIBRATION VERIFICATION CONTROLS1Cleared 510(K)
- K000230TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS1Cleared 510(K)
- K000318BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM1Cleared 510(K)
- K000056BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS1Cleared 510(K)
- K994200ACCESS HYBRITECH PSA QC, MODEL 372091Cleared 510(K)
- K994277ACCESS OSTASE QC1Cleared 510(K)
- K993210ACCESS HYBRITECH FREE PSA QC, MODEL 372191Cleared 510(K)
- K993642ELECSYS PARATHYROID HORMONE CALCHECK1Cleared 510(K)
- K981914TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION1Cleared 510(K)
- K991075ATLAST GLUCOSE CONTROL SOLUTION1Cleared 510(K)
- K990984VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS1Cleared 510(K)
- K990608ARCHITECT CEA MASTERCHECK, MODEL 6CO2-051Cleared 510(K)
- K990783VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS1Cleared 510(K)
- K990393ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-051Cleared 510(K)
- K990755SAS HCG URINE CONTROLS1Cleared 510(K)
- K990720SAS HCG SERUM CONTROLS1Cleared 510(K)
- K984604ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-051Cleared 510(K)
- K984625ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-051Cleared 510(K)
- K990026VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS1Cleared 510(K)
- K984626ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O51Cleared 510(K)
- K990162ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-011Cleared 510(K)
- K990061VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS1Cleared 510(K)
- K984319ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-051Cleared 510(K)
- K984327ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-051Cleared 510(K)
- K983432SUPREME II CONTROL SOLUTIONS1Cleared 510(K)
- K984323ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-051Cleared 510(K)
- K984318ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-051Cleared 510(K)
- K984324ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-051Cleared 510(K)
- K984011VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS1Cleared 510(K)
- K984071LIQUICHEK HOMOCYSTEINE CONTROL, CAT #6441Cleared 510(K)
- K984073ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-051Cleared 510(K)
- K984070ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-051Cleared 510(K)
- K984072ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-051Cleared 510(K)
- K983971CARDIAC MARKER CONTROL MODULE, MODEL CCCM1Cleared 510(K)
- K983578ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-051Cleared 510(K)
- K982471B2-MICROGLOBULIN CONTROL SET SERUM1Cleared 510(K)
- K982591DADE TRU-LIQUID CARDIAC CONTROL1Cleared 510(K)
- K982022VIGIL HEMOGLOBIN (HBALC) CONTROLS1Cleared 510(K)
- K981864ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 332191Cleared 510(K)
- K981622DADE TRU-LIQUID CARDIAC CONTROL1Cleared 510(K)
- K981281ELECSYS CALCHECK FERRITIN1Cleared 510(K)
- K981278ELECSYS CALCHECK CA 125II1Cleared 510(K)
- K974811ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL1Cleared 510(K)
- K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS1Cleared 510(K)
- K974609REP CHOLESTEROL PROFILE CONTROL-II1Cleared 510(K)
- K973676PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH1Cleared 510(K)
- K973678ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH1Cleared 510(K)
- K973677DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH1Cleared 510(K)
- K974383ELECSYS CALCHECK VITAMIN B121Cleared 510(K)
- K974108SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)1Cleared 510(K)
- K973832OPUS HLH CONTROLS1Cleared 510(K)
- K973358MYOGLOBIN CONTROL SET1Cleared 510(K)
- K973099PROSTATE SPECIFIC ANTIGEN CONTROL1Cleared 510(K)
- K973072WAKO NEFA LINEARITY SET1Cleared 510(K)
- K972721ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P1Cleared 510(K)
- K972687CARDIAC STATUS CONTROLS/TROPONIN I1Cleared 510(K)
- K972287DADE TRU-LIQUID BILIRUBIN CONTROL1Cleared 510(K)
- K971014LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS1Cleared 510(K)
- K970778LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,41Cleared 510(K)
- K971051IMMULITE THYROID AUTOANTIBODY CONTROL MODULE1Cleared 510(K)
- K970984THE ELECSYS CALCHECK PROGESTERONE1Cleared 510(K)
- K970459ELECSYS CALCHECK CEA1Cleared 510(K)
- K970458ELECSYS CALCHECK PSA1Cleared 510(K)
- K970452ELECSYS CALCHECK CEA1Cleared 510(K)
- K970527ABBOTT HCG SERUM CONTROLS1Cleared 510(K)
- K970148ELECSYS CALCHECK ESTRADIOL1Cleared 510(K)
- K970176HCG CONTROLS1Cleared 510(K)
- K970146ELECSYS CALCHECK TESTOSTERONE1Cleared 510(K)
- K964830ELECSYS CALCHECK LH1Cleared 510(K)
- K964278WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 61Cleared 510(K)
- K963909HEMOCUE GLUCOLIN1Cleared 510(K)
- K964053HEMOCUE GLUCOTROL1Cleared 510(K)
- K961432RADIAS GALT TEST1Cleared 510(K)
- K963551BIO-CSF LIQUID CONTROL LEVEL 1 AND 21Cleared 510(K)
- K963181ELECSYS CALCHECK T UPDATE1Cleared 510(K)
- K963165ELECSYS CALCHECK HCG1Cleared 510(K)
- K963240IMMULITE ACTH CONTROL MODULE (LACCM)1Cleared 510(K)
- K962975PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)1Cleared 510(K)
- K963164ELECSYS CALCHECK FT41Cleared 510(K)
- K963163ELECSYS CALCHECK FT31Cleared 510(K)
- K963167ELECYS CALCHECK T 31Cleared 510(K)
- K963178ELECSYS CALCHECK T41Cleared 510(K)
- K963182ELECSYS CALCHECK CK-MB1Cleared 510(K)
- K963147ELECSYS CALCHECK TSH1Cleared 510(K)
- K963143ELECSYS CALCHECK TROPONIN T1Cleared 510(K)
- K963085LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III1Cleared 510(K)
- K962841OPUS MYOGLOBIN CONTROLS1Cleared 510(K)
- K962694OPUS B12 CONTROLS1Cleared 510(K)
- K962573ELECSYS PRECICONTROL TSH1Cleared 510(K)
- K962432LIQUISPEX URINE (MICRO)ALBUMIN CONTROL1Cleared 510(K)
- K961510ACS FRT4 IMMUNOASSAY1Cleared 510(K)
- K960874COMPLEMENT CONTROL1Cleared 510(K)
- K961206OPUS T3 CONTROLS1Cleared 510(K)
- K960378ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS1Cleared 510(K)
- K955629LXN FRUCTOSAMINE TEST1Cleared 510(K)
- K960154PSA CONTROLS1Cleared 510(K)
- K955796IRON CALIBRATOR & CALIBRATION VERIFICATION SET1Cleared 510(K)
- K955468OPUS PROLACTIN CONTROLS1Cleared 510(K)
- K955141OSOM HCG COMBO TEST1Cleared 510(K)
- K953883ACCESS LOW LEVEL IGE CONTROLS1Cleared 510(K)
- K954144OPUS HCG CONTROLS1Cleared 510(K)
- K952251IMMULITE HCG HIGH LEVEL CONTROL MODULE1Cleared 510(K)
- K953097OPUS T4 CONTROLS1Cleared 510(K)
- K951888DADE STRATUS TROPONIN-I CONTROL1Cleared 510(K)
- K944999SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 31Cleared 510(K)
- K950072IMMULITE(R) TBG1Cleared 510(K)
- K950590REP CHOLESTEROL PROFILE CONTROL1Cleared 510(K)
- K950589CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL1Cleared 510(K)
- K946144LIQUISPEX(TM) URINE ETHANOL CONTROL1Cleared 510(K)
- K946143CHEMSPEX(TM) AMMONIA CONTROL1Cleared 510(K)
- K945718DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K944785SAS QUANT HCG SERUM1Cleared 510(K)
- K944361DOCUMENT R AMMONIA/ETHANOL CONTROL1Cleared 510(K)
- K944453QUANTITATE URIC ACID VERIFIER SET1Cleared 510(K)
- K944891SAS QUANT HCG URINE1Cleared 510(K)
- K944515SERUM PROTEIN CONTROLS1Cleared 510(K)
- K944338DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET1Cleared 510(K)
- K942632TNT TROPONIN T1Cleared 510(K)
- K942284CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET1Cleared 510(K)
- K941433HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH1Cleared 510(K)
- K935611AXSYM LUTEINIZING HORMONE (LH)1Cleared 510(K)
- K940577GLUCOMETER ELITE LOW CONTROL1Cleared 510(K)
- K941130ASSURE URINE HCG CONTROL1Cleared 510(K)
- K940142GLYCATED PROTEIN CONTROLS1Cleared 510(K)
- K940272ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL1Cleared 510(K)
- K940568DOCUMENT(R) ZERO1Cleared 510(K)
- K935606SERUM AMMONIA CONTROL1Cleared 510(K)
- K933218REFRACTOMETRIC, TOTAL PROTEIN1Cleared 510(K)
- K935362P-AMYLASE CONTROL1Cleared 510(K)
- K934923CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET1Cleared 510(K)
- K934922CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET1Cleared 510(K)
- K932479B-HCG HUMAN SERUM CONTROLS1Cleared 510(K)
- K934521SPQ MALB CONTROL LEVEL II1Cleared 510(K)
- K932660LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 21Cleared 510(K)
- K933744SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES1Cleared 510(K)
- K932178AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES1Cleared 510(K)
- K930007IMMULITE TSH THIRD GENERATION CONTROL1Cleared 510(K)
- K932870DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K932658CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 31Cleared 510(K)
- K932659MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM1Cleared 510(K)
- K932113CANNABINOID URINE CONTROLS1Cleared 510(K)
- K931761QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)1Cleared 510(K)
- K924859AIA-PACK IGE CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K930874LD-1 CONTROL-LEVEL 1 & 21Cleared 510(K)
- K925783AUTOSTAT ANTI-DSDNA1Cleared 510(K)
- K924860AIA-PACK AFP CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K925906NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL1Cleared 510(K)
- K922754TANDEM-E IGE II CALIBRATION VERIFICATION SET1Cleared 510(K)
- K925880KODAK AMERLITE CK-MB CONTROL SERA LAN.44131Cleared 510(K)
- K925479SUGAR CHEX LINEARITY FOR THE ONE TOUCH1Cleared 510(K)
- K926095REFRACTROL-SP1Cleared 510(K)
- K924852ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K924856AIA-PACK PRL CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K924493DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD1Cleared 510(K)
- K926015CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,31Cleared 510(K)
- K924853AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K924862AIA-PACK HCG CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K924675TSH - THIRD GENERATION LOW CONTROLS1Cleared 510(K)
- K924855AIA-PACK T-U CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K924863AIA-PACK FSH CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K924854AIA-PACK PAP CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K923821DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K923793DOCUMENT CHEM III CALIBRATION VERIFICATION TEST1Cleared 510(K)
- K923794DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K922995LIPID CONTROLS1Cleared 510(K)
- K922904RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II1Cleared 510(K)
- K921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL1Cleared 510(K)
- K920556TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET1Cleared 510(K)
- K921206HCG CONTROL1Cleared 510(K)
- K921089LYPHOCHEK(R) FRUCTOSAMINE CONTROL1Cleared 510(K)
- K915325TSH CONTROL1Cleared 510(K)
- K915806MILENIA DATA REDUCTION1Cleared 510(K)
- K914809MP MINI PHOTOMETER1Cleared 510(K)
- K913585LIPASE LINEARITY CONTROL1Cleared 510(K)
- K913792HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL1Cleared 510(K)
- K913346QUANTIMETRIX AMMONIA CONTROLS1Cleared 510(K)
- K913496CHOLINESTERASE LINEARITY CONTROL1Cleared 510(K)
- K912439TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET1Cleared 510(K)
- K911664DIRECTIGEN 1-2-3 PREGNANCY CONTROLS1Cleared 510(K)
- K911177ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II1Cleared 510(K)
- K911178ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III1Cleared 510(K)
- K911176ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I1Cleared 510(K)
- K905280BIOTROL BILIRUBIN C & T CONTROL1Cleared 510(K)
- K904503SERACON CR REFERENCE1Cleared 510(K)
- K904306DUPONT DRUG CALIBRATOR-A1Cleared 510(K)
- K903147CHEM-CHEX-ALT1Cleared 510(K)
- K902569PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF1Cleared 510(K)
- K902760AMERSHAM TSH CONTROL SERA1Cleared 510(K)
- K902867CHEM-CHEX BILIRUBIN1Cleared 510(K)
- K900719ROTAG CONTROLS1Cleared 510(K)
- K896875POSITIVE AND NEGATIVE HCG SERUM CONTROLS1Cleared 510(K)
- K895528GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.51041Cleared 510(K)
- K894400MICRO-PLATE READER, MDX-11Cleared 510(K)
- K894804SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)1Cleared 510(K)
- K894329RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL1Cleared 510(K)
- K894181POSITIVE AND NEGATIVE HCG URINE CONTROLS1Cleared 510(K)
- K891475LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,31Cleared 510(K)
- K893140DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET1Cleared 510(K)
- K885282ASSAYED CHOLINESTERASE CONTROL1Cleared 510(K)
- K892656DRI-DYE CHECK STRIPS (TM)-4051Cleared 510(K)
- K883741QTEST PREGNANCY TEST CONTROL1Cleared 510(K)
- K883316QUIDEL PREGNANCY TEST CONTROL1Cleared 510(K)
- K881430LIQUI-SERA SERUM ALCOHOL CONTROLS1Cleared 510(K)
- K880039AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 66651Cleared 510(K)
- K873342BILE ACIDS CONTROLS1Cleared 510(K)
- K873450TRI-LEVEL LIGAND CONTROL1Cleared 510(K)
- K873105REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL1Cleared 510(K)
- K870151TOTAL/IGE THEOPHYLLINE CONTROL SERA1Cleared 510(K)
- K863744HCG CONTROL KIT1Cleared 510(K)
- K863126TESTPACK ACUTE HCG SERUM CONTROLS1Cleared 510(K)
- K861221EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST1Cleared 510(K)
- K860453ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A70401Cleared 510(K)
- K855225ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL1Cleared 510(K)
- K853553DIASCAN CONTROL1Cleared 510(K)
- K851043SUGAR-CHEX II1Cleared 510(K)
- K851042SUGAR-CHEX1Cleared 510(K)
- K851079BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &31Cleared 510(K)
- K843569PRECISET AMMONIA1Cleared 510(K)
- K833898TRI-LEVEL BILIRUBIN CONTROLS1Cleared 510(K)
- K833097CHEM TRAK LIQUID BILIRUBIN CONTROL1Cleared 510(K)
- K831523BETA SCAN NORMAL CONTROL SOLUTION1Cleared 510(K)
- K831527SPINAL FLUID TOTAL PROTEIN CONTROL1Cleared 510(K)
- K830493PROTOPORPHYRIN ZN CONTROL1Cleared 510(K)
- K823421PHADEBAS HUMYLASE CONTROL(H)1Cleared 510(K)
- K830204DAC-CEL DIAGNATAL HCG STANDARDS RD491Cleared 510(K)
- K823687BIO INTERFERENCE BLANKING MATERIAL1Cleared 510(K)
- K823186ESTROCEPT STABILIZED ESTROGEN RECEPTOR1Cleared 510(K)
- K822219HUMAN PLASMA CONTROL FOR CEA-ROCHE1Cleared 510(K)
- K823353CARCINO-CEK1Cleared 510(K)
- K822938PHADEBASE HUMYLASE CONTROL1Cleared 510(K)
- K822698GLUCOSCAN CONTROLS1Cleared 510(K)
- K821742POSITIVE & NEGATIVE HCG URINE CONTROLS1Cleared 510(K)
- K821558LEVEL II CONTROL SERUM1Cleared 510(K)
- K820772FETAL-TEK CONTROL (IMMATURE/BORDERLINE)1Cleared 510(K)
- K812690C-PEPTIDE CONTROL PACK1Cleared 510(K)
- K811912HELENA VMA-SMC CONTROL1Cleared 510(K)
- K811832PRECINORM U & PRECIPATH U HUMAN SERUM1Cleared 510(K)
- K811150URINE PREGNANCY TEST STANDARD/CONTR. PK1Cleared 510(K)
- K802997HDL-CHOLESTEROL CONTROL SERUM1Cleared 510(K)
- K802068ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO1Cleared 510(K)
- K801854SPINAL FLUID CONTROL(HUMAN)1Cleared 510(K)
- K800708CODE QAS.105 PROLACTIN CONTROL SERA1Cleared 510(K)
- K800035PENTEX LIPOPROTEIN CHOLESTEROL SOLU.1Cleared 510(K)
- K792524CK-MB (CREATINE KINASE-MB) RIA CONTROL1Cleared 510(K)
- K791957SERACON -LO DO261Cleared 510(K)
- K791141BILIRUBIN CALIBRATOR CONTROL1Cleared 510(K)
- K791029NORMAL PROTEIN ELECTROPHORESIS CONTROL1Cleared 510(K)
- K791031ABNORMAL PROTEIN ELECTROPHORESIS CONTROL1Cleared 510(K)
- K790376DUPONT ACA CKMB VERIFIERS1Cleared 510(K)
- K790129SERUM PAK, HCG CONTROL1Cleared 510(K)
- K782170SERACON-LP1Cleared 510(K)
- K782171SERACON-HDL1Cleared 510(K)
- K772285ACA LIPASE VERIFIERS1Cleared 510(K)
- K771798ACA BILIRUBIN CALIBRATOR1Cleared 510(K)
- K771657EMIT THYROXINE CONTROL1Cleared 510(K)
- K770795SHAVE PREP SET1Cleared 510(K)
- K760885KETOTROL-E1Cleared 510(K)
- K760449LIPID CONTROL1Cleared 510(K)
- 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
- 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
- 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
- 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
- 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
- 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
FASTPACK CONTROL
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K003095
- 510(k) Type
- Abbreviated
- Applicant
- Qualigen, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/29/2000
- Days to Decision
- 57 days
- Submission Type
- Summary