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
- K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES1Cleared 510(K)
- K203597Cholesterol21Cleared 510(K)
- K190490VITROS XT Chemistry Products TRIG-CHOL Slides1Cleared 510(K)
- K181373Extended Lipid Panel Assay1Cleared 510(K)
- K180504Mission Lipid Panel Monitoring System1Cleared 510(K)
- K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System1Cleared 510(K)
- K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System1Cleared 510(K)
- K150654Cholesterol1Cleared 510(K)
- K132031AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL1Cleared 510(K)
- K130200PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM1Cleared 510(K)
- K122757ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT1Cleared 510(K)
- K120202EON CHOLESTEROL REAGENT1Cleared 510(K)
- K113262ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT1Cleared 510(K)
- K112538ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT1Cleared 510(K)
- K111753HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE1Cleared 510(K)
- K091413S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)1Cleared 510(K)
- K080623CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA1Cleared 510(K)
- K072249EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT1Cleared 510(K)
- K071593PTS PANELS CHOL+HDL PANEL TEST STRIPS1Cleared 510(K)
- K062026VAP-NT CHOLESTEROL TEST1Cleared 510(K)
- K051376ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE1Cleared 510(K)
- K042443SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL1Cleared 510(K)
- K031824COBAS INTEGRA CHOLESTEROL GEN. 21Cleared 510(K)
- K023642PICCOLO TOTAL CHOLESTEROL TEST SYSTEM1Cleared 510(K)
- K023558PTS PANELS LIPID PANEL TEST STRIPS1Cleared 510(K)
- K022898PTS PANELS LIPID PANEL TEST STRIPS1Cleared 510(K)
- K013173BIOSCANNER PLUS; LIPID PANEL TEST STRIPS1Cleared 510(K)
- K011970BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM1Cleared 510(K)
- K001032RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY1Cleared 510(K)
- K000610RESOLUTION CHOLESTEROL MONITOR1Cleared 510(K)
- K000900ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS1Cleared 510(K)
- K993096PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR1Cleared 510(K)
- K992803SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP1Cleared 510(K)
- K992132CHOLESITE TEST SYSTEM1Cleared 510(K)
- K991083RLP CHOLESTEROL IMMUNOSEPARATION ASSAY1Cleared 510(K)
- K990688MTM BIOSCANNER C TEST STRIPS1Cleared 510(K)
- K981345CHOLESTRON PRO II CHOLESTEROL TEST1Cleared 510(K)
- K982469HICHEM CHOLESTEROL REAGENT KIT1Cleared 510(K)
- K981181ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)1Cleared 510(K)
- K982118CARESIDE ANALYZER1Cleared 510(K)
- K981493MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 2201Cleared 510(K)
- K981652CHOL1Cleared 510(K)
- K981476CHOL1Cleared 510(K)
- K980667INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)1Cleared 510(K)
- K973284COBAS INTEGRA HDL-CHOLESTEROL DIRECT1Cleared 510(K)
- K972853CHOLESTEROL RAPID LIQUID REAGENT1Cleared 510(K)
- K971072CHOLESTEROL REAGENT1Cleared 510(K)
- K971505SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT1Cleared 510(K)
- K964660PARAMAX CHOLESTEROL REAGENT1Cleared 510(K)
- K971345CHOL OR CHOLESTEROL1Cleared 510(K)
- K962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)1Cleared 510(K)
- K960377ENA-C-T TOTAL CHOLESTEROL TEST1Cleared 510(K)
- K944458ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST1Cleared 510(K)
- K946161DMA TOTAL CHOLESTEROL PROCEDURE1Cleared 510(K)
- K952127BOEHRINGER MANNHEIM CHOLESTEROL ASSAY1Cleared 510(K)
- K950164PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR1Cleared 510(K)
- K943599CHEM TRAK ACCUMETER1Cleared 510(K)
- K946065TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL1Cleared 510(K)
- K946067TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL1Cleared 510(K)
- K946066TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL1Cleared 510(K)
- K946064TOTAL CHOLESTEROL CASSETTE1Cleared 510(K)
- K946063TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL1Cleared 510(K)
- K943027CHOLESTEROL QVET1Cleared 510(K)
- K941573ROCHE REAGENT1Cleared 510(K)
- K923504CHOLESTEROL ENZYMATIC ENDPOINT1Cleared 510(K)
- K935136CHOLESTEROL (CHOL) TEST ITEM NO. 654101Cleared 510(K)
- K934046BECKMAN CHOLESTEROL REAGENT1Cleared 510(K)
- K914432ACCUMETER(R) CHOLESTEROL SELF-TEST1Cleared 510(K)
- K925603OLYMPUS CHOLESTEROL REAGENT1Cleared 510(K)
- K924508CHOLESTEROL TEST ITEM# 42374/93, 42322/R11Cleared 510(K)
- K922231OLYMPUS CHOLESTEROL REAGENT1Cleared 510(K)
- K923733CHOLESTEROL TEST1Cleared 510(K)
- K923128KING DIAGNOSTICS CHOLESTEROL REAGENT1Cleared 510(K)
- K922612CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE1Cleared 510(K)
- K914160CHOLESTEROL REGEANT SET1Cleared 510(K)
- K913565ABBOTT QUICKSTART CHOLESTEROL TEST1Cleared 510(K)
- K914469CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL1Cleared 510(K)
- K912499KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST1Cleared 510(K)
- K912212PROACT CHOLESTEROL SYSTEMS1Cleared 510(K)
- K911692ENZYMATICS, INC., TOTAL CHOLESTEROL TEST1Cleared 510(K)
- K912136CHOLESTECH LIPID MONITORING SYS.1Cleared 510(K)
- K911578CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION1Cleared 510(K)
- K905405CHEMTRAK ACCUMETER CHOLESTEROL TEST1Cleared 510(K)
- K904031CHEMA CHOL CHOLESTEROL SYSTEM1Cleared 510(K)
- K905648CRP LIPID REAGENT TEST PACK1Cleared 510(K)
- K910240CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST1Cleared 510(K)
- K905145ECLIPSE ICA CHOLESTEROL1Cleared 510(K)
- K903126CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST1Cleared 510(K)
- K903015SYNERMED CHOLESTEROL REAGENT KIT1Cleared 510(K)
- K902678LIQUID STABLE CHOLESTEROL REAGENT KIT1Cleared 510(K)
- K902098CHOLESTEROL (RATE) REAGENT1Cleared 510(K)
- K901900L.D.X LIPID MONITORING SYSTEM1Cleared 510(K)
- K896467SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM1Cleared 510(K)
- K900850EMDS CHOLESTEROL (CHO), ITEM NUMBERS 654101Cleared 510(K)
- K897162COULTER CHOLESTEROL REAGENT1Cleared 510(K)
- K897036IMMUNOTECH CHOLESTEROL TEST1Cleared 510(K)
- K896239COBAS READY CHOLESTEROL REAGENT1Cleared 510(K)
- K895951CHOLESTEROL TEST KIT1Cleared 510(K)
- K896073CHOLESTEROL, UNIVERSAL ET1Cleared 510(K)
- K895158VISION WHOLE BLOOD HDL CHOLESTEROL1Cleared 510(K)
- K893916EMDS CHOLESTEROL (CHO), ITEM NUMBER 654101Cleared 510(K)
- K893479CHOLESTEROL REAGENT SET1Cleared 510(K)
- K891922AMRESCO CHOLESTEROL REAGENTS, PROD. # 73251Cleared 510(K)
- K892238CLA 200 CHEMPRO(R) LIPID ANALYZER1Cleared 510(K)
- K890334TOTAL CHOLESTEROL REAGENT1Cleared 510(K)
- K890027QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD1Cleared 510(K)
- K890267QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA1Cleared 510(K)
- K890990EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE1Cleared 510(K)
- K884757CLINISTAT CHOLESTEROL REAGENT TEST1Cleared 510(K)
- K885023CHOLESTEROL TEST ITEM NUMBER: SR10111Cleared 510(K)
- K883543HDL-CHOLESTEROL PRECIPITATING REAGENT1Cleared 510(K)
- K880723DIMENSION WHOLE BLOOD CHOLESTEROL1Cleared 510(K)
- K883844HI CHEM KINETIC CHOLESTEROL REAGENT #882181Cleared 510(K)
- K864159SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD1Cleared 510(K)
- K880237CHOLESTEROL1Cleared 510(K)
- K880311WAKO(TM) AUTOKIT CHOLESTEROL1Cleared 510(K)
- K875131(SKD) CHOLESTEROL TEST KIT1Cleared 510(K)
- K872930BIOTROL CHOLESTEROL ENZYMATIQUE COLOR1Cleared 510(K)
- K872575HDL CHOLESTEROL REAGENT1Cleared 510(K)
- K872295CHOLESTEROL REAGENT1Cleared 510(K)
- K871676ENZYMATIC CHOLESTEROL REAGENT SET1Cleared 510(K)
- K870928CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS1Cleared 510(K)
- K871260CHOLESTEROL DETERMINATION1Cleared 510(K)
- K870828INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT1Cleared 510(K)
- K870407EASY-TEST CHOLESTEROL(CHOL) NUMBER 166071Cleared 510(K)
- K863103PEG 6,0001Cleared 510(K)
- K864081U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST1Cleared 510(K)
- K863927CHOLESTEROL1Cleared 510(K)
- K863252CHOLESTEROL PROCEDURE1Cleared 510(K)
- K863062CHOLESTEROL-E (TOTAL)1Cleared 510(K)
- K863064CHOLESTEROL-E (FREE)1Cleared 510(K)
- K863063CHOLESTEROL-E FAST (TOTAL)1Cleared 510(K)
- K862707EMDS(TM) CHOLESTEROL TESTPACK, # 67685/951Cleared 510(K)
- K862507FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)1Cleared 510(K)
- K861659CHOLESTEROL PROCEDURE1Cleared 510(K)
- K861700DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM1Cleared 510(K)
- K860717ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL)1Cleared 510(K)
- K855028TOTAL CHOLESTEROL REAGENT SET1Cleared 510(K)
- K854426KODAK EKTACHEM HDL CHOLESTEROL KIT1Cleared 510(K)
- K855187ENZYMATIC CHOLESTROL REAGENT SET1Cleared 510(K)
- K854179IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL1Cleared 510(K)
- K853854ASTRA SYSTEMS CHOLESTEROL REAGENT1Cleared 510(K)
- K853871QCA ENZYMATIC CHOLESTEROL1Cleared 510(K)
- K852863CHOLESTEROL METHOD1Cleared 510(K)
- K850390CHOLESTEROL TEST SYSTEM1Cleared 510(K)
- K852009T-CHO REAGENT1Cleared 510(K)
- K844655PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE1Cleared 510(K)
- K844242CHOLESTEROL REAGENT FOR DEMAND ANALYZER1Cleared 510(K)
- K843510PDA CHOLESTEROL1Cleared 510(K)
- K843222ENZYMATIC CHOLESTEROL KIT1Cleared 510(K)
- K843327SYSTEMATE CHOLESTEROL 672221Cleared 510(K)
- K842160CHOLESTEROL ASSSAY KIT1Cleared 510(K)
- K842320TDX REA CHOLESTEROL1Cleared 510(K)
- K842441AXIOM STABLE II CHOLESTEROL TEST1Cleared 510(K)
- K841182MULTIPLE CHEM. MODULE FOR ANALYSIS1Cleared 510(K)
- K841053CHOLESTEROL REAGENT SET ENZYMATIC1Cleared 510(K)
- K840776PARAMAX CHOLESTEROL REAGENT1Cleared 510(K)
- K840368DURAZYME CHOLESTEROL1Cleared 510(K)
- K840189TOTAL CHOLESTEROL REAGENT SET1Cleared 510(K)
- K832780FLOW-PAC SHOLESTEROL REAGENT SET1Cleared 510(K)
- K832158CHOLESTEROL HIGH PERFORMANCE-K1Cleared 510(K)
- K831863CHOLESTEROL-ENZYMATIC REAGENT SET1Cleared 510(K)
- K831700MULTICHEM ENZYMATIC CHOLESTEROL SYS1Cleared 510(K)
- K831687WAKO CHOLESTEROL CII1Cleared 510(K)
- K830761WAKO FREE CHOLESTEROL C TEST1Cleared 510(K)
- K830239ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA1Cleared 510(K)
- K830309ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE1Cleared 510(K)
- K823784ENZYMATIC CHOLESTEROL (COLORIMETRIC1Cleared 510(K)
- K823500CHOLESTEROL REAGENT1Cleared 510(K)
- K823354ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE1Cleared 510(K)
- K823302CHOLESTEROL CHOD-PAP TEST1Cleared 510(K)
- K823187CHOLESTEROL HIGH SENSIT. REAGENT ENZYM1Cleared 510(K)
- K822417NEW ENZYMATIC SINGLE REAGENT FREE CHOL.1Cleared 510(K)
- K822418ULTRACHEM ENZYMATIC CHOL. OXIDASE1Cleared 510(K)
- K821441ENZYMATIC CHOLESTERAL OXIDASE #6505501Cleared 510(K)
- K821105CHOLESTEZYME-V EIKEN1Cleared 510(K)
- K820951ENZYMATIC CHOLESTEROL KIT1Cleared 510(K)
- K820950TOTAL CHOLESTEROL REAGENT SET1Cleared 510(K)
- K820473ENZYMATIC CHOLESTEROL REAGENT SYSTEM1Cleared 510(K)
- K820263KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES1Cleared 510(K)
- K813039ULTRACHEM E-CHOL, ITEM #650251Cleared 510(K)
- K812293CENTRICHEM CHOLESTEROL REAGENT & CALIBRA1Cleared 510(K)
- K812100SERALYZER1Cleared 510(K)
- K812091FAST CHOLES-CINET1Cleared 510(K)
- K811760CHOLESTEROL DETERMINATION1Cleared 510(K)
- K810673ENZYMATIC CHOLESTEROL1Cleared 510(K)
- K810405CHOLESTEROL REAGENT1Cleared 510(K)
- K803287CHOLESTEROL REAGENT ENZYMATIC1Cleared 510(K)
- K803254LIQUID-STAT REAGENT FOR ASSAY OF CHOLES.1Cleared 510(K)
- K802743AMES SERA-PAK CHOLESTEROL REAGENT KIT1Cleared 510(K)
- K801285YSI MODELS 23C & 23CM HDL & TOTAL CHOLES1Cleared 510(K)
- K801296COBAS REAGENT FOR CHOLESTEROL1Cleared 510(K)
- K800765CENTRIFICHEM CHOLESTEROL1Cleared 510(K)
- K800457LIQUID-STAT LIQUID REAGENT1Cleared 510(K)
- K800199LINEAR ENZYMATIC CHOLESTEROL SYSTEM1Cleared 510(K)
- K792509ACA HIGH DENSITY LIPOPROTEIN CHOLES.1Cleared 510(K)
- K792478CHEM-STRATE CHOLESTEROL1Cleared 510(K)
- K791511ENZYMATIC REAGENT SET, 4X250 ML.1Cleared 510(K)
- K790947AUTO ENZYMATIC CHOLESTEROL1Cleared 510(K)
- K790768WAKO CHOLESTEROL TEST1Cleared 510(K)
- K790760REAGENT SYSTEM #350HDL, SIGMA PROCEDURE1Cleared 510(K)
- K790724ENZYMATIC DETERMINATION1Cleared 510(K)
- K790556CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC1Cleared 510(K)
- K781740REAGENT, HDL1Cleared 510(K)
- K781721REAGENT SET, CHOLESTEROL1Cleared 510(K)
- K781013ENZYMATIC REAGENT FOR CHOLESTEROL MEAS1Cleared 510(K)
- K780659HDL CHOLESTEROL1Cleared 510(K)
- K780783AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT1Cleared 510(K)
- K780638ACCESSORY HDL CHOLESTEROL REAGENT SET1Cleared 510(K)
- K780635REAGENT SET HDL CHOLESTEROL1Cleared 510(K)
- K780523ULTRACHEM ENZYMATIC CHOLESTEROL 650251Cleared 510(K)
- K780389HDL REAGENT SET FOR LIPOPROTEINS1Cleared 510(K)
- K780331CHOLESTEROL RAPID SLAT KIT HDL1Cleared 510(K)
- K772311WISP MODEL 7101Cleared 510(K)
- K771731CHOLAR PRODU&T #170101Cleared 510(K)
- K771820ENZYMATIC CHOLESTEROL1Cleared 510(K)
- K771586CHOLOPAP-HDL1Cleared 510(K)
- K771582HOLESTEROL DELTA TEST ASSAY1Cleared 510(K)
- K771508MULTISTAT III CHOLESTEROL TEST1Cleared 510(K)
- K771067CHOLESTEROL KIT1Cleared 510(K)
- K770909ENZYMATIC CHOLESTEROL REAGENT SET1Cleared 510(K)
- K770780REAGENTS1Cleared 510(K)
- K770483CHOLESTEROL REAGENT1Cleared 510(K)
- K770998CHOLESTEROL REAGENT SET1Cleared 510(K)
- K770747REAGENT SET, CHOLESTEROL, CAT NO. 40241Cleared 510(K)
- K770265CHOLESTEROL TEST1Cleared 510(K)
- K761136GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT1Cleared 510(K)
- K761089GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT1Cleared 510(K)
- K761263CHOLESTEROL AUTOMATED REAGENT1Cleared 510(K)
- CHILipase-Esterase, Enzymatic, Photometric, Lipase1Product Code
- CHJMercuric Thiocyanate, Colorimetry, Chloride2Product Code
- CHKMercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride2Product Code
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph2Product Code
- CHMRadioimmunoassay, Total Estrogens In Pregnancy1Product Code
- CHORadioimmunoassay, Cyclic Amp2Product Code
- CHPRadioimmunoassay, Estradiol1Product Code
- CHQChromatographic/Fluorometric Method, Catecholamines1Product Code
- CHRTitrimetric Phenol Red, Carbon-Dioxide2Product Code
- CHSCoulometric Method, Carbon-Dioxide2Product Code
- CHTElectrophoretic Method, Catecholamines1Product Code
- CHWTitrimetric With Edta And Indicator, Calcium2Product Code
- CHZDi (O-Hydroxyphenylimine) Ethane, Calcium2Product Code
- CIAMethylthymol Blue, Calcium2Product Code
- CIBRadioimmunoassay, Angiotensin I And Renin2Product Code
- CICCresolphthalein Complexone, Calcium2Product Code
- CIDAlizarin Sulfonate, Calcium2Product Code
- CIEVolumetric/Manometric, Carbon-Dioxide2Product Code
- CIFVanillin Pyruvate, Ast/Sgot2Product Code
- CIGDiazo Colorimetry, Bilirubin2Product Code
- CIJSaccharogenic, Amylase2Product Code
- CIKRadial Diffusion, Amylase2Product Code
- CILCresol Red Colorimetry, Carbon-Dioxide2Product Code
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes2Product Code
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CIQDiazo, Ast/Sgot2Product Code
- CISHydrazone Colorimetry, Ast/Sgot2Product Code
- CITNadh Oxidation/Nad Reduction, Ast/Sgot2Product Code
- CIWStarch-Dye Bound Polymer, Amylase2Product Code
- CIXBromcresol Green Dye-Binding, Albumin2Product Code
- CIYRadioimmunoassay, Androsterone1Product Code
- CIZRadioimmunoassay, Androstenedione1Product Code
- CJAAmyloclastic, Amylase2Product Code
- CJBChromatographic Separation/Radioimmunoassay, Aldosterone2Product Code
- CJCFructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase1Product Code
- CJDNitrosalicylate Reduction, Amylase2Product Code
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJFTetrabromophenolphthalein, Albumin2Product Code
- CJGTetrabromo-M-Cresolsulfonphthalein, Albumin2Product Code
- CJHThymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJIDisodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJJDiazo, Alt/Sgpt1Product Code
- CJKPhenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJLBeta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJMRadioimmunoassay, Aldosterone2Product Code
- CJNAcid Phosphatase, Nitrophenylphosphate2Product Code
- CJOAlpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJQRadial Immunodiffusion, Albumin2Product Code
- CJRAcid Phosphatase, Thymol Blue Monophosphate2Product Code
- CJTHydrazone Colorimetry, Aldolase1Product Code
- CJWBromcresol Purple Dye-Binding, Albumin2Product Code
- CJXAcid Phosphatase, Disodium Phenylphosphate2Product Code
- CJYAzo Dye, Calcium2Product Code
- CJZAcid, Hydroxyazobenzene-Benzoic, Albumin2Product Code
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt1Product Code
- CKBAcid Phosphatase, Naphthyl Phosphate2Product Code
- CKCVanillin Pyruvate, Alt/Sgpt1Product Code
- CKDHydrazone Colorimetry, Alt/Sgpt1Product Code
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate2Product Code
- CKFPhenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CKGRadioimmunoassay, Acth2Product Code
- CKHAcid Phosphatase, Beta Glycerophosphate2Product Code
- DHASystem, Test, Human Chorionic Gonadotropin2Product Code
- GIMTubes, Vacuum Sample, With Anticoagulant2Product Code
- GJETray, Blood Collection2Product Code
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited2Product Code
- JFJCatalytic Methods, Amylase2Product Code
- JFLPh Rate Measurement, Carbon-Dioxide2Product Code
- JFMEnzymatic Method, Bilirubin2Product Code
- JFNAtomic Absorption, Calcium2Product Code
- JFOFluorometric, Calcium2Product Code
- JFPElectrode, Ion Specific, Calcium2Product Code
- JFSCoulometric, Chloride2Product Code
- JFTFluorometric, Cortisol2Product Code
- JFYEnzymatic Method, Creatinine2Product Code
- JGCTryptophan Measurement (Colorimetric), Globulin1Product Code
- JGDNephelometric Method, Globulin1Product Code
- JGETurbidimetric Method, Globulin1Product Code
- JGFDifferential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes2Product Code
- JGGL-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase1Product Code
- JGIAtomic Absorption, Magnesium1Product Code
- JGJPhotometric Method, Magnesium1Product Code
- JGKFerric Chloride, Phenylketones (Urinary, Non-Quant.)1Product Code
- JGMFlame Photometry, Potassium2Product Code
- JGPLowry (Colorimetric), Total Protein2Product Code
- JGQTurbidimetric, Total Protein2Product Code
- JGRRefractometric, Total Protein2Product Code
- JGSElectrode, Ion Specific, Sodium2Product Code
- JGTFlame Photometry, Sodium2Product Code
- JGWFluorometric Method, Triglycerides1Product Code
- JGXTurbidimetric Method, Triglycerides1Product Code
- JGYColorimetric Method, Triglycerides1Product Code
- JGZO-Phthalaldehyde, Urea Nitrogen2Product Code
- JHAAcid, Uric, Uricase (Gasometric)1Product Code
- JHCAcid, Uric, Uricase (Oxygen Rate)1Product Code
- JHDFluorometric Method, 17-Hydroxycorticosteroids1Product Code
- JHERadioassay, 17-Hydroxycorticosteroids1Product Code
- JHFColorimetric Method, Lecithin/Sphingomyelin Ratio2Product Code
- JHGChromatographic Separation, Lecithin/Sphingomyelin Ratio2Product Code
- JHHElectrophoretic Method, Lecithin/Sphingomyelin Ratio2Product Code
- JHIVisual, Pregnancy Hcg, Prescription Use2Product Code
- JHJAgglutination Method, Human Chorionic Gonadotropin2Product Code
- JHLMicrodensitometry Method, Lipoproteins1Product Code
- JHMColorimetric Method, Lipoproteins1Product Code
- JHNTurbidimetric Method, Lipoproteins1Product Code
- JHOElectrophoretic Separation, Lipoproteins1Product Code
- JHPRadial Immunodiffusion, Lipoproteins1Product Code
- JHQNephelometric Method, Lipoproteins1Product Code
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes2Product Code
- JHTChromatographic Separation, Cpk Isoenzymes2Product Code
- JHWU.V. Method, Cpk Isoenzymes2Product Code
- JHXFluorometric Method, Cpk Or Isoenzymes2Product Code
- JHYColorimetric Method, Cpk Or Isoenzymes2Product Code
- JIAEnzymatic Methods, Galactose1Product Code
- JIBU.V. Method, Galactose1Product Code
- JICColorimetric Method, Galactose1Product Code
- JIDPhotometric Method, Ammonia1Product Code
- JIEMethod, Ion-Exchange, Ammonia1Product Code
- JIFEnzymatic Method, Ammonia1Product Code
- JIGElectrode, Ion-Specific Method, Ammonia1Product Code
- JIJWet Ash Method, Protein-Bound Iodine1Product Code
- JIKDry Ash Method, Protein-Bound Iodine1Product Code
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)2Product Code
- JIMMethod, Metallic Reduction, Glucose (Urinary, Non-Quantitative)2Product Code
- JINNitroprusside, Ketones (Urinary, Non-Quant.)1Product Code
- JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)1Product Code
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)1Product Code
- JISCalibrator, Primary2Product Code
- JITCalibrator, Secondary2Product Code
- JIWCalibrator, Surrogate2Product Code
- JIXCalibrator, Multi-Analyte Mixture2Product Code
- JIYPhotometric Method, Iron (Non-Heme)1Product Code
- JIZAtomic Absorption, Iron (Non-Heme)1Product Code
- JJARadio-Labeled Iron Method, Iron (Non-Heme)1Product Code
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)1Product Code
- JJRElectrolyte Controls (Assayed And Unassayed)1Product Code
- JJSControls For Blood-Gases, (Assayed And Unassayed)1Product Code
- JJTEnzyme Controls (Assayed And Unassayed)1Product Code
- JJWUrinalysis Controls (Assayed And Unassayed)1Product Code
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1Product Code
- JJYMulti-Analyte Controls, All Kinds (Assayed)1Product Code
- JKATubes, Vials, Systems, Serum Separators, Blood Collection2Product Code
- JKBRadioimmunoassay, Compound S (11-Deoxycortisol)1Product Code
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)1Product Code
- JKDRadioimmunoassay, C-Peptides Of Proinsulin1Product Code
- JKFDinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge1Product Code
- JKGL-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase1Product Code
- JKHHydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen1Product Code
- JKJFluorometric Measurement, Porphyrins1Product Code
- JKLAcid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry1Product Code
- JKPChromium-51, Blood Volume1Product Code
- JKRRadioimmunoassay, Calcitonin2Product Code
- JKWN-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin1Product Code
- JKXN-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin1Product Code
- JKYOxalydihydrazide (Spectroscopic), Copper1Product Code
- JKZDiethyldithiocarbamate (Colorimetric), Copper1Product Code
- JLAConversion To Creatinine, Creatine1Product Code
- JLBAtp And Creatine Kinase (Enzymatic), Creatine1Product Code
- JLCNitroprusside Reaction (Qualitative, Urine), Cystine1Product Code
- JLDChromatographic, Cystine1Product Code
- JLERadioimmunoassay, Desoxycorticosterone1Product Code
- JLFRadioimmunoassay, Etiocholanolone1Product Code
- JLGConversion To Ferric Hydroxymates (Colorimetric), Fatty Acids1Product Code
- JLHTitrimetric, Fatty Acids1Product Code
- JLITetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid1Product Code
- JLJUridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate2Product Code
- JLKSodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity1Product Code
- JLLTubeless Analysis, Gastric Acidity1Product Code
- JLNChromatographic, Glutathione1Product Code
- JLOEnzymatic (Glutathione Reductase), Glutathione1Product Code
- JLPSpectrophotometric Method, Pregnanediol1Product Code
- JLQSpectrophotometric Method, Pregnanetriol1Product Code
- JLRGas Chromatography, Pregnanetriol1Product Code
- JLSRadioimmunoassay, Progesterone1Product Code
- JLTAcid, Pyruvic, Enzymatic (U.V.)1Product Code
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone2Product Code
- JLXRadioimmunoassay, 17-Hydroxyprogesterone1Product Code
- JLYPhosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid1Product Code
- JLZNadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid1Product Code
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)1Product Code
- JMDRadioimmunoassay, Total Estrogens, Nonpregnancy1Product Code
- JMERadioimmunoassay, Glucagon1Product Code
- JMFRadioimmunoassay, Human Placental Lactogen2Product Code
- JMIChromatographic, Histidine1Product Code
- JMJMicrobiological, Histidine1Product Code
- JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase1Product Code
- JMMColumn Chromatography & Color Development, Hydroxyproline1Product Code
- JMNExtraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline1Product Code
- JMOFerrozine (Colorimetric) Iron Binding Capacity1Product Code
- JMQM. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)1Product Code
- JMRImmunochemical, Lysozyme (Muramidase)1Product Code
- JMSAcid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase1Product Code
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)1Product Code
- JMW2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen)1Product Code
- JMXNinhydrin, Nitrogen (Amino-Nitrogen)1Product Code
- JMYCitrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase1Product Code
- JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality1Product Code
- JNAVapor Pressure, Osmolality Of Serum & Urine1Product Code
- JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine2Product Code
- JNCColumn Or Paper Chromatography Plus Ninhydrin, Phenylalanine2Product Code
- JNDNadp Reduction, 6-Phosphogluconate Dehydrogenase1Product Code
- JNEGlucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase1Product Code
- JNFIon-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen1Product Code
- JNGRadioimmunoassay, Pregnenolone1Product Code
- JNJPhosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase1Product Code
- JNKBeta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase1Product Code
- JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin1Product Code
- JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin1Product Code
- JNPInfrared Spectroscopy Measurement, Urinary Calculi (Stone)1Product Code
- JNQQualitative Chemical Reactions, Urinary Calculi (Stone)1Product Code
- JNSStannous Chloride - Hydrazine, Phospholipids1Product Code
- JNTChromatographic, Phospholipids1Product Code
- JNXMembrane Osmometry, Plasma Oncometry1Product Code
- JNYGlyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate Isomerase1Product Code
- JNZFluorometric, Uroporphyrin1Product Code
- JOAAcid, Trifluoroacetic, Vitamin A, Hexane Extraction1Product Code
- JOBHexane Extraction, Fluorescence, Vitamin E1Product Code
- JOCColorimetric, Xylose1Product Code
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase1Product Code
- JQAElectrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes1Product Code
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase1Product Code
- JQDResin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity1Product Code
- JQEResin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity1Product Code
- JQFBathophenanthroline, Iron Binding Capacity1Product Code
- JQGRadiometric, Fe59, Iron Binding Capacity1Product Code
- JQHTrinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen)1Product Code
- JQIRotating Disc, Plasma Viscometry1Product Code
- JQJDensitometeric, Protein Fractionation1Product Code
- JQKImmunodiffusion, Protein Fractionation1Product Code
- JQLSpectrophotometric, Uroporphyrin1Product Code
- JQMP-Bromoaniline, Xylose1Product Code
- JQNColorimetric, Mucopolysaccharides1Product Code
- KHMNephelometric, Amylase2Product Code
- KHPAcid, Lactic, Enzymatic Method1Product Code
- KHQRadioassay, Triiodothyronine Uptake2Product Code
- KHSEnzymatic, Carbon-Dioxide2Product Code
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine2Product Code
- KLJNad Reduction (U.V.), Phosphohexose Isomerase1Product Code
- KMSPhenolphthalein Colorimetry, Carbon-Dioxide2Product Code
- KNKAcid, Uric, Uricase (Colorimetric)1Product Code
- KQNRadioassay, Angiotensin Converting Enzyme2Product Code
- KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase2Product Code
- KWWRadioimmunoassay, Cholyglycine, Bile Acids2Product Code
- KWXRadioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids2Product Code
- LBRLdl & Vldl Precipitation, Hdl1Product Code
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1Product Code
- LBTElectrophoresis, Cholesterol Via Esterase-Oxidase, Hdl1Product Code
- LCHTonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical1Product Code
- LCXKit, Test, Pregnancy, Hcg, Over The Counter2Product Code
- LFPConductivity Rate, Urea Nitrogen2Product Code
- LFQAcid, Uric, Acid Reduction Of Ferric Ion1Product Code
- LFRGlucose Dehydrogenase, Glucose2Product Code
- LFSRadioreceptor Assay, Human Chorionic Gonadotropin2Product Code
- LIGRadioassay, Intrinsic Factor Blocking Antibody2Product Code
- LPSUrinary Homocystine (Nonquantitative) Test System2Product Code
- LPTSystem, Test, Urinary Methylmalonic Acid2Product Code
- LPWSystem, Test, Oxalate1Product Code
- MMIImmunoassay Method, Troponin Subunit2Product Code
- MPGUrinary Carbohydrate Analysis Kit1Product Code
- MQMBilirubin (Total And Unbound) In The Neonate Test System1Product Code
- MRGSystem, Test, Vitamin D2Product Code
- MRRSystem, Test, Low Density, Lipoprotein1Product Code
- MRVDrink, Glucose Tolerance2Product Code
- MSJApolipoproteins1Product Code
- MSMSystem, Test, Lipoprotein(A)1Product Code
- MYTBiosensor, Immunoassay, Cpk Or Isoenzymes2Product Code
- MZUSystem, Test, Sodium, Enzymatic Method2Product Code
- MZVTest, System, Potassium, Enzymatic Method2Product Code
- NAKSystem, Test, Biotinidase2Product Code
- NALTest, Immunoassay, Biosensor, Hcg2Product Code
- NAOTest, Carbohydrate Deficient Transferrin1Product Code
- NAQLipoprotein, High Density, Hdl, Over The Counter1Product Code
- NBCTest, Natriuretic Peptide2Product Code
- NBWSystem, Test, Blood Glucose, Over The Counter2Product Code
- 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
- 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
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- 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 REAGENT
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K941573
- 510(k) Type
- Traditional
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/31/1994
- Days to Decision
- 214 days
- Submission Type
- Statement