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
- K240998ABL90 FLEX PLUS System2Cleared 510(K)
- K230285i-STAT CG8+ cartridge with the i-STAT 1 System2Cleared 510(K)
- K221900Stat Profile Prime Plus Analyzer System2Cleared 510(K)
- K223857i-STAT G3+ cartridge with the i-STAT 1 System2Cleared 510(K)
- K223608GEM Premier 7000 with IQM32Cleared 510(K)
- K211559EasyStat 3002Cleared 510(K)
- K203790GEM Premier 50002Cleared 510(K)
- K200986OPTI® B-Lac Cassette2Cleared 510(K)
- K200107epoc Blood Analysis System2Cleared 510(K)
- K200492i-STAT CG4+ Cartridge with the i-STAT 1 System2Cleared 510(K)
- K192240RAPIDPoint 500e Blood Gas System2Cleared 510(K)
- K193246Stat Profile Prime Plus Analyzer System2Cleared 510(K)
- K173797Stat Profile Prime Plus Analyzer System2Cleared 510(K)
- K173403GEM Premier 50002Cleared 510(K)
- K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)2Cleared 510(K)
- K160153ABL90 FLEX PLUS2Cleared 510(K)
- K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control2Cleared 510(K)
- K151982Stat Profile Prime ABG Analyzer System2Cleared 510(K)
- K151856ABL80 FLEX CO-OX with AQURE connectivity2Cleared 510(K)
- K142898ABL800 FLEX with AQURE connectivity2Cleared 510(K)
- K141907STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A2Cleared 510(K)
- K142220Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)2Cleared 510(K)
- K131703NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM2Cleared 510(K)
- K133407GEM PREMIER 40002Cleared 510(K)
- K131988ABL90 FLEX ANALYZER2Cleared 510(K)
- K131126OPTI CCA-TS22Cleared 510(K)
- K130144ABL90 FLEX2Cleared 510(K)
- K123748ABL90 FLEX2Cleared 510(K)
- K122539MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM2Cleared 510(K)
- K122729ABL90 FLEX2Cleared 510(K)
- K122642ABL90 FLEX2Cleared 510(K)
- K111188COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B2Cleared 510(K)
- K120197ABL90 FLEX2Cleared 510(K)
- K110648NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM2Cleared 510(K)
- K111897ABL902Cleared 510(K)
- K110416ABL835 FLEX ANALYZER WITH PLEURAL PH2Cleared 510(K)
- K093280OPTI CCA-TS, B-LAC CASSETTE MODEL BP75612Cleared 510(K)
- K100777ABL837 FLEX ANALYZER2Cleared 510(K)
- K080370ABL 80 CO-OX SYSTEM2Cleared 510(K)
- K063376EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER2Cleared 510(K)
- K061974GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT2Cleared 510(K)
- K051804ABL80 FLEX ANALYZER2Cleared 510(K)
- K043218ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX2Cleared 510(K)
- K050423OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)2Cleared 510(K)
- K041874ABL800 FLEX2Cleared 510(K)
- K031560BAYER RAPIDLAB 1200 SYSTEM2Cleared 510(K)
- K023567STAT PROFILE PHOX PLUS L ANALYZER2Cleared 510(K)
- K022746STAT PROFILE CRITICAL CARE XPRESS ANALYZER2Cleared 510(K)
- K021713STAT PROFILE PHOX PLUS C ANALYZER2Cleared 510(K)
- K021515EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER2Cleared 510(K)
- K020297STAT PROFILE CRITICAL CARE XPRESS ANALYZER2Cleared 510(K)
- K014295STAT PROFILE PHOX ANALYZER2Cleared 510(K)
- K013729STAT PROFILE PHOX BASIC ANALYZER2Cleared 510(K)
- K012478MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER2Cleared 510(K)
- K012058STAT PROFILE PHOX PLUS L ANALYZER2Cleared 510(K)
- K002738BAYER RAPIDPOINT 400 SYSTEM2Cleared 510(K)
- K002613MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER2Cleared 510(K)
- K002290ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)2Cleared 510(K)
- K000103AVL OPTI R ANALYZER2Cleared 510(K)
- K994346ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM2Cleared 510(K)
- K993789CLINICAL BLOOD GAS MIXTURE2Cleared 510(K)
- K992859ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE2Cleared 510(K)
- K992834GEM PREMIER 30002Cleared 510(K)
- K991417ABL 735 ANALYZER2Cleared 510(K)
- K990092AVL OMNI MODULAR ANALYZER2Cleared 510(K)
- K982928NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM2Cleared 510(K)
- K9843846.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-4972Cleared 510(K)
- K982277MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)2Cleared 510(K)
- K980991NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER2Cleared 510(K)
- K980523IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE2Cleared 510(K)
- K980130ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM2Cleared 510(K)
- K974526EASYBLOOD GAS ANALYZER2Cleared 510(K)
- K974396IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE2Cleared 510(K)
- K973367ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM2Cleared 510(K)
- K970710STAT PROFILE ULTRA M ANALYZER2Cleared 510(K)
- K963964AVL COMPACT 3 PH/BLOOD GAS ANALYZER2Cleared 510(K)
- K963800IL SYNTHESIS2Cleared 510(K)
- K961335GEM PREMIER PLUS MODEL 55002Cleared 510(K)
- K961657CIBA CORNING 400 SYSTEM2Cleared 510(K)
- K962021CIBA CORNING 348 SYSTEM2Cleared 510(K)
- K961161AVL OPTI 1 PH/BLOOD GAS ANALYZER2Cleared 510(K)
- K955793IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM2Cleared 510(K)
- K954482SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM2Cleared 510(K)
- K954711STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)2Cleared 510(K)
- K953935MED-TECH CLINICAL BLOOD GAS2Cleared 510(K)
- K954612ABL SYSTEM 625, 615, 6052Cleared 510(K)
- K943882ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM2Cleared 510(K)
- K936203STAT PROFILE PLUS 10 ANALYZER2Cleared 510(K)
- K946206CIBA CORNING 8-- SERIES CO-OXIMETER2Cleared 510(K)
- K945240IRMA BLOOD ANALYSIS SYSTEM2Cleared 510(K)
- K943643STAT PROFILE ULTRA 11 ANALYZER2Cleared 510(K)
- K944089AVL OPTI PH/BLOOD GAS ANALYZER2Cleared 510(K)
- K943570AVL COMPACT 1 PH/BLOOD GAS ANALYZER2Cleared 510(K)
- K942616AVL COMPACT 2 PH/BLOOD GAS ANALYZER2Cleared 510(K)
- K935655ABL5 BLOOD GAS SYSTEM2Cleared 510(K)
- K935121ABL SYSTEM 6202Cleared 510(K)
- K940918I-STAT 200 PORTABLE CLINICAL ANALYZER2Cleared 510(K)
- K935069IL1430 BGELECTROLYTE ANALYZER2Cleared 510(K)
- K936081I-STAT TESTS FOR ACID-BASE PARAMETERS2Cleared 510(K)
- K935830CIBA CORNING 248 PH/BLOOD GAS ANALYZER2Cleared 510(K)
- K934907860 MEASURMENT SYSTEM2Cleared 510(K)
- K932642AVL 9110PH ANALYZER2Cleared 510(K)
- K924497STAT PROFILE 9 ANALYZER2Cleared 510(K)
- K924758DMI BLOOD GAS ANALYZER/CARTRIDGE2Cleared 510(K)
- K922631STATPAL II BLOOD GAS ANALYSIS SYSTEM2Cleared 510(K)
- K922922ABL50 BLOOD GAS SYSTEM2Cleared 510(K)
- K914166ABL505 BLOOD GAS & ELECTROLYTE SYSTEM2Cleared 510(K)
- K915087DMI BLOD GAS ANALYZER/CARTRIDGE2Cleared 510(K)
- K914560STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL2Cleared 510(K)
- K913927IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST2Cleared 510(K)
- K903965STATPAL BLOOD GAS MONITORING SYSTEM2Cleared 510(K)
- K904513ABL510 BLOOD GAS SYSTEM2Cleared 510(K)
- K904188CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER2Cleared 510(K)
- K902267BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS2Cleared 510(K)
- K895317AVL MODEL 995HB PH/BLOOD GAS ANALYZER2Cleared 510(K)
- K895181ABL500 BLOOD GAS SYSTEM2Cleared 510(K)
- K890827IL1400, BGELECTROLYTE ANALYZER2Cleared 510(K)
- K891578AVL MODEL 987 ELECTROLYTE ANALYZER2Cleared 510(K)
- K884267ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS2Cleared 510(K)
- K884143NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER2Cleared 510(K)
- K882941BLOOD GAS MIXTURE2Cleared 510(K)
- K882209MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES2Cleared 510(K)
- K881188BLOOD PH CAPILLARY TUBES, HEPARIN2Cleared 510(K)
- K873577GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK2Cleared 510(K)
- K871397ANALYZER: NOVA STAT PROFILE 3 ANALYZER2Cleared 510(K)
- K865036CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM2Cleared 510(K)
- K864445STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL2Cleared 510(K)
- K863880BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.2Cleared 510(K)
- K860057ABL330 ACID BASE LABORATORY2Cleared 510(K)
- K853840LIFE WATCH RESPIRATORY MONITOR2Cleared 510(K)
- K854608ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT.2Cleared 510(K)
- K853405ELECTROLYTE ANALYZER SERA-2522Cleared 510(K)
- K852790ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT2Cleared 510(K)
- K852676IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS2Cleared 510(K)
- K850360ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS2Cleared 510(K)
- K844781MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB2Cleared 510(K)
- K844295ABL300 ACID BASE LABORATORY2Cleared 510(K)
- K842519BLOOD GAS FLUSH SOL. & FLUSH AGENT 13022Cleared 510(K)
- K841609COMPONENTS FOR PARTIAL PRESSURE ELEE2Cleared 510(K)
- K840843POTASSIUM CHLORIDE TABLETS2Cleared 510(K)
- K840468PARTIAL PRESS. ELECTRODE MEASUREMENT2Cleared 510(K)
- K840300FLUSH SOLUTION CONCENTRATE-BLOOD GAS2Cleared 510(K)
- K834601AVL MODEL 945 BLOOD GAS SYSTEM2Cleared 510(K)
- K833536PARTIAL PRESSURE ELECTRODE MEASUREMENT2Cleared 510(K)
- K833534PARTIAL PRESSURE ELECTRODE MEASUREMENT2Cleared 510(K)
- K832981ELECTRODES FOR BLOOD GAS ANALYZERS2Cleared 510(K)
- K832779REFEREE BLOOD GAS ANALYZER-ELECTRODES2Cleared 510(K)
- K831379MODEL 947 VIDEO BLOOD GAS SYS2Cleared 510(K)
- K831019PH 6.838 REF. BUFFER2Cleared 510(K)
- K831025ELECTROLYLE CARBON DIOXIDE ELECTRODES2Cleared 510(K)
- K831024ELECTROLYTE PO2 FOR OXYGEN ELECTRODES2Cleared 510(K)
- K831021CALIBRATING SOLUTION FOR ABL-1 & 22Cleared 510(K)
- K831018CALIBRATING SOLUTION FOR ABL-1 & 22Cleared 510(K)
- K831023REFERENCE BUFFER PH 7.3822Cleared 510(K)
- K831013DIAGNOSTICS PO 2 ELECTROLYTE2Cleared 510(K)
- K831012DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON2Cleared 510(K)
- K831015DIAGNOSTICS PH ELECTRODE CLEANING SOLUT2Cleared 510(K)
- K831017BUFFER PACK FOR ABL-1 & ABL-22Cleared 510(K)
- K831020FLUSH SOLUTION CONCENTRATE2Cleared 510(K)
- K831010DIAGNOSTICS PO2 ELECTRODE CLEANER2Cleared 510(K)
- K831016BATH CLEAR2Cleared 510(K)
- K823750CLEANING AGENT2Cleared 510(K)
- K823570CORNING 170 PH/BLOOD GAS ANALYZER2Cleared 510(K)
- K821483IL 1302 PH BLOOD GAS ANALYZER2Cleared 510(K)
- K820744IL MODEL 1301, PH BLOOD GAS SYSTEM2Cleared 510(K)
- K820597158 BLOOD GAS ANALYZER2Cleared 510(K)
- K813517BLOOD GAS ANALYSIS, STANDARDS CONTROLS2Cleared 510(K)
- K812090LORENZ BLOOD GAS ANALYZER2Cleared 510(K)
- K812623CLEANING SOLUTION FOR RADIOMETER OSM22Cleared 510(K)
- K812552COROMETRICS MEDICAL SYST. 220 PH ANALY.2Cleared 510(K)
- K810724CORNING 178 BLOOD GAS ANALYZER2Cleared 510(K)
- K810308ARTERIAL MICROCOLLECTION SET2Cleared 510(K)
- K800757IL MODEL 1303 PH/BLOOD GAS ANALYZER2Cleared 510(K)
- K800271COROMETRICS MEDICAL SYSTEMS 220 PH SYS.2Cleared 510(K)
- K800224RADIOMETER ACID BASE LABORATORY-ABL-32Cleared 510(K)
- K792230AVL MODEL 940 AUTOMATIC PH/BLOOD GAS2Cleared 510(K)
- K781968BLOOD GAS SYSTEM MODEL 1682Cleared 510(K)
- K780716TECHNICON BGII ANALYZER2Cleared 510(K)
- K772307PCO 2 ELECTROLYTE2Cleared 510(K)
- K771822BG II ANALYZER2Cleared 510(K)
- K771147AVL BLOOD GAS INSTRUMENT MODEL 9392Cleared 510(K)
- K771253HEMOX-ANALYZER2Cleared 510(K)
- K770736MONITOR, PATIENT, MODEL PM-20N2Cleared 510(K)
- K760969PH/BLOOD GAS SYSTEM2Cleared 510(K)
- K760748REAGENTS FOR BLOOD GAS INSTRUMENTATION2Cleared 510(K)
- K760229ACID BASE SYSTEM, RADIOMETER AUTOMATED2Cleared 510(K)
- 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
- 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
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GEM Premier 5000
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K173403
- 510(k) Type
- Traditional
- Applicant
- Instrumentation Laboratory Co.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/29/2017
- Days to Decision
- 59 days
- Submission Type
- Summary