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
- K161140VITROS Chemistry Products Calibrator Kit 32Cleared 510(K)
- K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator2Cleared 510(K)
- K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II2Cleared 510(K)
- K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)2Cleared 510(K)
- K141388SYSTEM CALIBRATER2Cleared 510(K)
- K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN2Cleared 510(K)
- K130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II2Cleared 510(K)
- K123321DIMENSION CHEMISTRY III CALIBRATORY2Cleared 510(K)
- K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR2Cleared 510(K)
- K122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS2Cleared 510(K)
- K112834MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES2Cleared 510(K)
- K112029ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-052Cleared 510(K)
- K110394ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)2Cleared 510(K)
- K110251SYNCHRON MULTI CALIBRATOR2Cleared 510(K)
- K103701ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS2Cleared 510(K)
- K103171ELECSYS ANTI-TPO CALSET2Cleared 510(K)
- K103403MULTICONSTITUENT CALIBRATOR2Cleared 510(K)
- K103612DIMENSION VISA ENZ 2 CAL2Cleared 510(K)
- K101456ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM2Cleared 510(K)
- K101460LOCI 8 CALIBRATOR, MODEL KC 6462Cleared 510(K)
- K100778DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A2Cleared 510(K)
- K093732ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 103767702Cleared 510(K)
- K093645EXL ANEM CAL, MODEL RC6402Cleared 510(K)
- K092113STA - FREE PS CALIBRATOR2Cleared 510(K)
- K090283CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL32Cleared 510(K)
- K080404EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR2Cleared 510(K)
- K083579DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC3602Cleared 510(K)
- K081533SENTINEL PLASMAPROTEINS CAL 3X2Cleared 510(K)
- K081103LOCI THYROID CALIBRATOR WITH MODEL RC6102Cleared 510(K)
- K073612URIC ACID (AOX), SCAL, NORTROL, ABTROL2Cleared 510(K)
- K080607CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 113552791602Cleared 510(K)
- K071779ABX PENTRA URINE CAL2Cleared 510(K)
- K072435DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H2Cleared 510(K)
- K072204ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS2Cleared 510(K)
- K071801VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-26592Cleared 510(K)
- K070971MODIFICATION TO SENTINEL CLIN CHEM CAL2Cleared 510(K)
- K070207MULTI-ANALYTE CHEMISTRY CALIBRATOR2Cleared 510(K)
- K063508DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN2Cleared 510(K)
- K062035DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL2Cleared 510(K)
- K062334DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC1302Cleared 510(K)
- K062319CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 3602Cleared 510(K)
- K062034DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)2Cleared 510(K)
- K062122DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)2Cleared 510(K)
- K061923DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)2Cleared 510(K)
- K061838DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC1102Cleared 510(K)
- K061750DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC2202Cleared 510(K)
- K062055DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH2Cleared 510(K)
- K061703DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)2Cleared 510(K)
- K061056RANDOX LIQUID PROTEIN CALIBRATOR2Cleared 510(K)
- K061390DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC3202Cleared 510(K)
- K061218DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC1402Cleared 510(K)
- K060940VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III2Cleared 510(K)
- K053153RANDOX CALIBRATION SERUM2Cleared 510(K)
- K051452SENTINEL CLIN CHEM CAL2Cleared 510(K)
- K051619LIPOPROTEIN FOR MULTIPLE ANALYTES2Cleared 510(K)
- K051457SENTINEL PLASMAPROTEINS CAL 3X2Cleared 510(K)
- K050026PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC2Cleared 510(K)
- K043460OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR00712Cleared 510(K)
- K041926HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-2782Cleared 510(K)
- K042551MULTI-CHEM CALIBRATOR A2Cleared 510(K)
- K042550MULTI-LIPID CALIBRATOR2Cleared 510(K)
- K042549MULTI CHEM CAL B2Cleared 510(K)
- K042243MICROALBUMIN MULTI-CALIBRATOR SET2Cleared 510(K)
- K041905HEMOSIL CALIBRATION PLASMA2Cleared 510(K)
- K041870N APOLIPOPROTEIN STANDARD SERUM2Cleared 510(K)
- K040264CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF2Cleared 510(K)
- K040245CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)2Cleared 510(K)
- K032936DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR2Cleared 510(K)
- K033873ELECSYS C-PEPTIDE CALSET2Cleared 510(K)
- K033791BAYER SPECIFIC PROTEIN REFERENCE SERUM2Cleared 510(K)
- K033910OLYMPUS URINE CALIBRATOR2Cleared 510(K)
- K033380BAYER SPECIAL CHEMISTRY CALIBRATORS2Cleared 510(K)
- K032665OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR00712Cleared 510(K)
- K033501MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)2Cleared 510(K)
- K033061CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE2Cleared 510(K)
- K032287MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 22Cleared 510(K)
- K031608RANDOX LIQUID PROTEIN CALIBRATOR2Cleared 510(K)
- K031683TOX AMMONIA CALIBRATOR2Cleared 510(K)
- K031880AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL2Cleared 510(K)
- K031682LIPOPROTEIN CALIBRATOR2Cleared 510(K)
- K030804BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR2Cleared 510(K)
- K030621ATAC CALIBRATOR2Cleared 510(K)
- K024305WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 19180062Cleared 510(K)
- K030169SETPOINT CHEMISTRY CALIBRATOR2Cleared 510(K)
- K023792CALIBRATION PACK, MODELS A9100-101S AND A9100-103S2Cleared 510(K)
- K030074LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS2Cleared 510(K)
- K023876VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 12Cleared 510(K)
- K023268PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS2Cleared 510(K)
- K023158RANDOX APOLIPOPROTEIN CALIBRATOR2Cleared 510(K)
- K022767RAICHEM LIPID CALIBRATOR2Cleared 510(K)
- K022108THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-0502Cleared 510(K)
- K013397PACIFIC HEMOSTASIS REFERENCE EMULSION2Cleared 510(K)
- K020129PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE2Cleared 510(K)
- K013178DC-UIBC-CO2-CAL, MODEL SE-1532Cleared 510(K)
- K012987PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER2Cleared 510(K)
- K012509PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM2Cleared 510(K)
- K012470MODIFICATION TO N PROTEIN STANDARD SL2Cleared 510(K)
- K012250RAICHEM MULTI-ANALYTE CALIBRATOR2Cleared 510(K)
- K011658CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS2Cleared 510(K)
- K011226CALIBRATOR FOR AUTOMATED SYSTEMS2Cleared 510(K)
- K011035DIMENSION DRUG CALIBRATOR, MODEL DC22B2Cleared 510(K)
- K010652SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S29362Cleared 510(K)
- K010030LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR2Cleared 510(K)
- K002804N PROTEIN STANDARD SL2Cleared 510(K)
- K001484CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-8382Cleared 510(K)
- K000576ELECSYS CORTISOL CALCHECK2Cleared 510(K)
- K993853K-ASSAY MULTI-ANALYTE CALIBRATOR2Cleared 510(K)
- K993606K-ASSAY APO A1/B CALIBRATOR SET2Cleared 510(K)
- K992845HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT2Cleared 510(K)
- K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-0032Cleared 510(K)
- K992086OLYMPUS SERUM PROTEIN MULTICALIBRATOR 22Cleared 510(K)
- K991166K-ASSAY MICROALBUMIN CALIBRATOR SET2Cleared 510(K)
- K991181MODIFICATION OF N PROTEIN STANDARD SL2Cleared 510(K)
- K990460CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)2Cleared 510(K)
- K984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR2Cleared 510(K)
- K984014SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 22Cleared 510(K)
- K983469PRECISET SERUM PROTEINS CALIBRATOR2Cleared 510(K)
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- K981706AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 22Cleared 510(K)
- K981795CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO2Cleared 510(K)
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- K981436DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-1092Cleared 510(K)
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- K974290MICROPROTEIN STANDARD KIT2Cleared 510(K)
- K973932BECKMAN CALIBRATOR 2 (CAL2)2Cleared 510(K)
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- K971333SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD2Cleared 510(K)
- K970921STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)2Cleared 510(K)
- K964527N RHEUMATOLOGY STANDARD SL2Cleared 510(K)
- K964829ELECSYS CALCHECK FSH2Cleared 510(K)
- K964062N PROTEIN STRANDARD SL2Cleared 510(K)
- K963543SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 22Cleared 510(K)
- K963533SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 12Cleared 510(K)
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- K960085ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS2Cleared 510(K)
- K955154CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT2Cleared 510(K)
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- K940760FLUIDS PACK FOR CORING 2382Cleared 510(K)
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- K942549ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS2Cleared 510(K)
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- K897071ROCHE STANDARDS FOR THE COBAS ISE MODULE2Cleared 510(K)
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- K875304BIOTROL CALIBRANT LEVEL 22Cleared 510(K)
- K875288BIOTROL CALIBRANT LEVEL 12Cleared 510(K)
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- K872789PARAMAX URINE/CSF CALIBRATOR2Cleared 510(K)
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- K871183FLAME PHOTOMETER STANDARD #60082 140 NA/5K2Cleared 510(K)
- K871182FLAME PHOTOMETER STANDARD #60081 120 NA/2K2Cleared 510(K)
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- K855199PARAMAX COMPREHENSIVE CALIBRATOR2Cleared 510(K)
- K854092DMA CALIBRATORS2Cleared 510(K)
- K851990INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU2Cleared 510(K)
- K851939CORNING CERTAIN -ISE2Cleared 510(K)
- K851151FISHER DIAGNOSTICS KDA CALIBRATOR II2Cleared 510(K)
- K851150FISHER DIAGNOSTICS KDA CALIBRATOR I2Cleared 510(K)
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- K844585REFERRIL CALIBRATORS2Cleared 510(K)
- K844026SERACON TM SR IV2Cleared 510(K)
- K844027SERACON TM SR III2Cleared 510(K)
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- K841464CHANGES IN THE CHEMICAL COMP. OF 52Cleared 510(K)
- K841456VENTREXYME EIA CONTROLS IMMUNOASSAY2Cleared 510(K)
- K841419SODIUM & POTASSIUM STANDARD SOLUT2Cleared 510(K)
- K841420SODIUM & POTASSIUM STANDARD SOL 802Cleared 510(K)
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- K830341SALT BRIDGE SOLUTION & URINE DILUENT2Cleared 510(K)
- K823044KM-KAL L32Cleared 510(K)
- K823042KM-KAL L12Cleared 510(K)
- K823046KM-KAL L52Cleared 510(K)
- K823045KM-KAL L42Cleared 510(K)
- K823043KM-KAL L22Cleared 510(K)
- K822937GLUCOSE/UREA NITROGEN STANDARD2Cleared 510(K)
- K822289CO2/CI STANDARDS2Cleared 510(K)
- K821885REF. ELECTRODE SOL'N.;STANDARD B2Cleared 510(K)
- K821794NOVA V FLUIDS PACK & EXTERNAL STANDARDS2Cleared 510(K)
- K821623NOVA IV FLUIDS PACK & EXTERNAL STANDARDS2Cleared 510(K)
- K821030NOVA II FLUIDS PACK2Cleared 510(K)
- K820947NOVA III FLUIDS PACK2Cleared 510(K)
- K820701NOVA I FLUIDS PACK2Cleared 510(K)
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- K802825COMBINED GLUCOSE AND BUN STANDARDS2Cleared 510(K)
- K802824COMBUNED CALCIUM AND PHOSPHORUS STD.2Cleared 510(K)
- K802632ALBUMIN/TOTAL PROTEIN STANDARDS2Cleared 510(K)
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- K800043CESIUM DILUENT (1.5 MM/L)2Cleared 510(K)
- K800041SODIUM/POTASSIUM 140/5 MEQ/L)2Cleared 510(K)
- K792486SERACON-SRI (PROD. # D0292Cleared 510(K)
- K792487SERACON-SRII2Cleared 510(K)
- K792485SERACON-SRI2Cleared 510(K)
- K792384PRINCIPAL ANALYTE REFERENCE SERUM2Cleared 510(K)
- K792013LANCER L-INA HUMAN REFERENCE SERUM2Cleared 510(K)
- K791874CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD2Cleared 510(K)
- K791956SERACON CAL D0252Cleared 510(K)
- K791694CALIBRATOR II2Cleared 510(K)
- K791693CALIBRATOR I2Cleared 510(K)
- K782039SERACON-N2Cleared 510(K)
- K782037SERACON-A2Cleared 510(K)
- K781758SERACON-SRII2Cleared 510(K)
- K781757SERACON-SRI2Cleared 510(K)
- K781702CALIBRATOR, BOVINE SERUM2Cleared 510(K)
- K780553COMP. CLIN. CHEM. REF. SERUM-BENCHMARK2Cleared 510(K)
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- 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
- PSL25-Oh-Vitamin D Mass Spectrometry Test System2Product Code
- PTCUric Acid Test System For At Home Prescription Use1Product Code
- PYPLow-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test1Product Code
- PYVHospital Continuous Glucose Monitoring System2Product Code
- PZIPrescription Use Blood Glucose Meter For Near-Patient Testing2Product Code
- QBJIntegrated Continuous Glucose Monitoring System, Factory Calibrated2Product Code
- QCCInsulin Pump Therapy Adjustment Calculator For Healthcare Professionals2Product Code
- QCLAcid-Sphingomyelinase (Asm) Newborn Screening Test System2Product Code
- QCMß-Galactocerebrosidase (Galc) Newborn Screening Test System2Product Code
- QDHMenopause Test System2Product Code
- QDKIntegrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management2Product Code
- QDLIntegrated Continuous Glucose Monitoring System For Professional Retrospective Use2Product Code
- QEIBreast Milk Macronutrients Test System2Product Code
- QIIIntegrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use2Product Code
- QJEMuscular Dystrophy Newborn Screening Test2Product Code
- QJIInteroperable Automated Glycemic Controller2Product Code
- QJSInteroperable Automated Glycemic Controller, Insulin Suspend2Product Code
- QLGIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems2Product Code
- QMABlood Collection Device For Cell-Free Nucleic Acid2Product Code
- QQBPrognostic Test For Assessment Of Liver Related Disease Progression2Product Code
- OJQCardiac Allograft Gene Expression Profiling Test System2Product Code
- QRXContinuous Glucose Monitor Informed Insulin Dose Calculator2Product Code
- QZGMenstrual Blood Collection Device2Product Code
- SAFIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter2Product Code
- SBHIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter2Product Code
- SFOElectrode Measurement, Drain Effluent Ph2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ROCHE STANDARDS FOR THE COBAS ISE MODULE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K897071
- 510(k) Type
- Traditional
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/9/1990
- Days to Decision
- 77 days