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
- K230275i-STAT CG8+ cartridge with the i-STAT 1 System2Cleared 510(K)
- K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)2Cleared 510(K)
- K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer2Cleared 510(K)
- K213486GLP systems Track2Cleared 510(K)
- K200403Stat Profile Prime Plus Analyzer System2Cleared 510(K)
- K183688i-STAT CHEM8+ cartridge with the i-STAT 1 System2Cleared 510(K)
- K191365Stat Profile Prime ES Comp Plus Analyzer System2Cleared 510(K)
- K172232LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 6002Cleared 510(K)
- K183549GEM Premier ChemSTAT2Cleared 510(K)
- K180428Stat Profile Prime Plus Analyzer System2Cleared 510(K)
- K181201Synermed ISE Reagents2Cleared 510(K)
- K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)2Cleared 510(K)
- K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)2Cleared 510(K)
- K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer2Cleared 510(K)
- K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator2Cleared 510(K)
- K153357i-STAT Alinity System with i-STAT Sodium test2Cleared 510(K)
- K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer2Cleared 510(K)
- K151767Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator2Cleared 510(K)
- K140373ISE INDIRECT NA, K, C1 FOR GEN 22Cleared 510(K)
- K132418COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 22Cleared 510(K)
- K123726COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 22Cleared 510(K)
- K121140PROLYTE ELECTROLYTE ANALYZER2Cleared 510(K)
- K102647ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...2Cleared 510(K)
- K102959PROLYTE ELECTROLYTE ANALYZER2Cleared 510(K)
- K100829EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 5202Cleared 510(K)
- K100673EASYLYTE NA/K/CL/LI ANALYZER, MODEL 20202Cleared 510(K)
- K091861VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 79272Cleared 510(K)
- K082462GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+2Cleared 510(K)
- K081411VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 22Cleared 510(K)
- K070104PROLYTE ELECTROLYTE ANALYZER2Cleared 510(K)
- K061597EPOC BLOOD ANALYSIS SYSTEM2Cleared 510(K)
- K053110Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge2Cleared 510(K)
- K053165ISE INDIRECT NA, K, CL FOR GEN.22Cleared 510(K)
- K052724TECO ISE REAGENT SET FOR CX SYSTEM2Cleared 510(K)
- K051646ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH2Cleared 510(K)
- K040977GENCHEM ELECTROLYTE BUFFER2Cleared 510(K)
- K040971GENCHEM ISE ELECTROLYTE REFERENCE2Cleared 510(K)
- K023049SYNCHRON LX I 725 CLINICAL SYSTEM2Cleared 510(K)
- K020364PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS2Cleared 510(K)
- K011213MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM2Cleared 510(K)
- K002407EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER2Cleared 510(K)
- K002855BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER2Cleared 510(K)
- K001761STATLYTE NA/K/CL/LI ANALYZER2Cleared 510(K)
- K001154I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER2Cleared 510(K)
- K000895STAT PROFILE PHOX PLUS ANALYZER2Cleared 510(K)
- K992842HICHEM ISE ELECTROLYTE REFERENCE2Cleared 510(K)
- K992844HICHEM ISE ELECTROLYTE BUFFER2Cleared 510(K)
- K993211PICCOLO SODIUM TEST SYSTEM2Cleared 510(K)
- K990346BAYER ADVIA 1650 CHEMISTRY SYSTEM2Cleared 510(K)
- K990036CARESIDE LYTES, CARESIDE ANALLYZER MODEL 10002Cleared 510(K)
- K963763EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER2Cleared 510(K)
- K963627(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE2Cleared 510(K)
- K962334EML105 ELECTROLYTE METABOLITE ANALYZER2Cleared 510(K)
- K963542SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT2Cleared 510(K)
- K961099EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)2Cleared 510(K)
- K955375EASYSTAT SODIUM/POTASSIUM ANALYZER2Cleared 510(K)
- K955374EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER2Cleared 510(K)
- K952179SYNERMED ISE REAGENTS2Cleared 510(K)
- K941400SYNERMED ISE REAGENTS2Cleared 510(K)
- K935120EML 1002Cleared 510(K)
- K940194SYNERMED ISE REAGENTS2Cleared 510(K)
- K932179MODEL 400/450 ELECTROLYTE ANALYZER2Cleared 510(K)
- K933862ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)2Cleared 510(K)
- K933373CIBA CORNING 300 SERIES SYSTEM2Cleared 510(K)
- K925612HI CHEM ELECTROLYTE BUFFER2Cleared 510(K)
- K925611HI CHEM ELECTROLYTE REFERENCE REAGENT2Cleared 510(K)
- K924547NOVA 8 CRT ANALYZER2Cleared 510(K)
- K924471KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)2Cleared 510(K)
- K923806ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER2Cleared 510(K)
- K921937NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION2Cleared 510(K)
- K921718OLYMPUS ISE MODULE2Cleared 510(K)
- K922215NOVA 14 NA/K/CL/GLU/BUN ANALYZER2Cleared 510(K)
- K915176NOVA 4 NA/K/C1/TCO2/LI ANALYZER2Cleared 510(K)
- K914810EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER2Cleared 510(K)
- K903564MEDISENSOR 20012Cleared 510(K)
- K912648ISE/NA+2Cleared 510(K)
- K912560NOVA 12 ANALYZER2Cleared 510(K)
- K912559NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER2Cleared 510(K)
- K912387I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK2Cleared 510(K)
- K912016IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER2Cleared 510(K)
- K910305GEM-PREMIER SYSTEM2Cleared 510(K)
- K910554CLINAK(TM) ISE SUBSYSTEM2Cleared 510(K)
- K905264STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS2Cleared 510(K)
- K905600TECHLYTE ELECTROLYTE ANALYZER2Cleared 510(K)
- K904335SECONDARY CALIBRATORS2Cleared 510(K)
- K903188ABBOTT VISION LYTE (TM) SODIUM2Cleared 510(K)
- K901042IONOMETER EF-HK AND ACCESSORIES2Cleared 510(K)
- K901040IONOMETER EH-F AND ACCESSORIES2Cleared 510(K)
- K896526LYTENING(TM) 5, LYTENING(TM) SYSTEM 302Cleared 510(K)
- K895936EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER2Cleared 510(K)
- K894035EOS CHEMISTRY ANALYZER2Cleared 510(K)
- K895672TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD2Cleared 510(K)
- K894914MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK2Cleared 510(K)
- K894218NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM2Cleared 510(K)
- K892500CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE2Cleared 510(K)
- K882801RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.2Cleared 510(K)
- K882104ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT.2Cleared 510(K)
- K880750NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT2Cleared 510(K)
- K880917LYTENING 52Cleared 510(K)
- K881255NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA2Cleared 510(K)
- K874832NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL2Cleared 510(K)
- K875263ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R)2Cleared 510(K)
- K874185DART (R) ELECTROLYTE REAGENT SYSTEM2Cleared 510(K)
- K873126SODIUM/POTASSIUM REAGENT KIT2Cleared 510(K)
- K873074SODIUM AND POTASSIUM BY ION SELECTIVE2Cleared 510(K)
- K872716CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE2Cleared 510(K)
- K872190NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER2Cleared 510(K)
- K871028CIBA CORNING MODEL 664/FAST 4 SYSTEM2Cleared 510(K)
- K870183IONOMETER EF AND ACCESSORIES2Cleared 510(K)
- K864872MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER2Cleared 510(K)
- K864862REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.2Cleared 510(K)
- K863907MODIFIED SODIUM ELECTRODE2Cleared 510(K)
- K863521LYTENING 22Cleared 510(K)
- K863617ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)2Cleared 510(K)
- K862819AVL MODEL 984 ELECTROLYTE ANALYZER2Cleared 510(K)
- K861696ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 7042Cleared 510(K)
- K861967AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT SET2Cleared 510(K)
- K861087AVL MODEL 983 ELECTROLYTE ANALYZER2Cleared 510(K)
- K853832LYTENING 12Cleared 510(K)
- K852595DC-3 FLUIDS PACK, DC-5 FLUIDS PACK2Cleared 510(K)
- K852473ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA2Cleared 510(K)
- K850209QUICK-LYTE2Cleared 510(K)
- K844587AVL MODEL 982 ELECTROLYTE ANALYZER2Cleared 510(K)
- K844559MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI2Cleared 510(K)
- K843530CORNING 614 NA/K ANALYZER2Cleared 510(K)
- K843453ULTRA LYTE SODIUM REAGENT KIT2Cleared 510(K)
- K842873STANDARDS & ACCESSORIES FOR NOVA INSTRU2Cleared 510(K)
- K843452STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ2Cleared 510(K)
- K842025ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL2Cleared 510(K)
- K841424ELECTROLYTE ANALYZER SERA-2102Cleared 510(K)
- K841418SODIUM ELECTRODE RINSE SOLUTION 22Cleared 510(K)
- K841417POTASSIUM CHLORIDE SOLUTION -2 MOLAR2Cleared 510(K)
- K840557REAGENTS & STANDARDS IL 501 NA/K2Cleared 510(K)
- K833992TECHNICON RA-1000 SYSTEM2Cleared 510(K)
- K833712NA/K FLUIDA PACK FOR NOVA 1 ANALYZER2Cleared 510(K)
- K833072TECHNICON RA-1000 SYS-ISE MODULE &2Cleared 510(K)
- K833036FLOW-PAC SODIUM REAGENT SET2Cleared 510(K)
- K832744STARLYTE2Cleared 510(K)
- K832415DEPROTEINIZING & CLEANING SOLUTION2Cleared 510(K)
- K832070AMRESCO NA/K REAGENT SET2Cleared 510(K)
- K830588POTASSIUM ANALYZER-SODIUM/ELECTROLYTE2Cleared 510(K)
- K830589ELECTROLYTE STANDARD - CORNING NALK ISE2Cleared 510(K)
- K822039BECKMAN ASTRA2Cleared 510(K)
- K820395LIQUIZYME NA+/K+ REAGENT SET2Cleared 510(K)
- K812762IL 501, NA/K ANALYZER2Cleared 510(K)
- K811896902 NA/K2Cleared 510(K)
- K811289NOVA 52Cleared 510(K)
- K810135MODEL AM 721 ELECTROLYTE ANALYZER2Cleared 510(K)
- K802155REAGENTS SERUM SODIUM USING THE TECH.2Cleared 510(K)
- K801896BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM2Cleared 510(K)
- K801882NOVA 4 SODIUM/POTASSIUM/CHLORIDE/CARBON2Cleared 510(K)
- K801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.2Cleared 510(K)
- K801011AVL #980 ELECTROLYTE ANALYZER2Cleared 510(K)
- K800676REAGENTS FOR DETERM. SODIUM IN HUMAN SUM2Cleared 510(K)
- K801007IL SYSTEM 502 NA/K ANALYZER2Cleared 510(K)
- K800628KODAK EKTACHEM CLINICAL CHEM. SLIDES2Cleared 510(K)
- K800584NSI SODIUM/POTASSIUM KIT2Cleared 510(K)
- K800216SODIUM/POTASSIUM CONDITIONING REAGENT2Cleared 510(K)
- K791691SODIUM/POTASSIUM CONDITIONING SOLUTION2Cleared 510(K)
- K771839SODIUM2Cleared 510(K)
- K770601ANALYZER, SODIUM/POTASSIUM NOVA L2Cleared 510(K)
- 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
- 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
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- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
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- RadiologyReview Panel
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- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ISE INDIRECT NA, K, CL FOR GEN.2
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K053165
- 510(k) Type
- Special
- Applicant
- ROCHE DIAGNOSTICS CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/14/2005
- Days to Decision
- 30 days
- Submission Type
- Summary