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
- K210933YSI 2900C Biochemistry Analyzer2Cleared 510(K)
- K220328EasyStat 3002Cleared 510(K)
- K223179Cholestech LDX ™ System2Cleared 510(K)
- K223755i-STAT G cartridge with the i-STAT 1 System2Cleared 510(K)
- K223710i-STAT CG8+ cartridge with the i-STAT 1 System2Cleared 510(K)
- K223090GEM Premier ChemSTAT2Cleared 510(K)
- K203549Nova Primary Glucose Analyzer System2Cleared 510(K)
- K210958i-STAT CHEM8+ cartridge with the i-STAT 1 System2Cleared 510(K)
- K200349Stat Profile Prime Plus Analyzer System2Cleared 510(K)
- K183678i-STAT CHEM8+ cartridge with the i-STAT 1 System2Cleared 510(K)
- K190520VITROS XT Chemistry Products GLU-Ca Slides2Cleared 510(K)
- K183546GEM Premier ChemSTAT2Cleared 510(K)
- K182781PTS Professional Chemistry Kit2Cleared 510(K)
- K180340Stat Profile Prime Plus Analyzer System2Cleared 510(K)
- K163433VITROS Chemistry Products GLU Slides2Cleared 510(K)
- K163271i-Stat Alinity System with i-Stat Glucose test2Cleared 510(K)
- K162282CardioChek Plus Test System, CardioChek Home Test System2Cleared 510(K)
- K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)2Cleared 510(K)
- K161818GEM Premier 30002Cleared 510(K)
- K153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer2Cleared 510(K)
- K151639ABL80 FLEX and ABL80 FLEX CO-OX2Cleared 510(K)
- K142689GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System2Cleared 510(K)
- K151530CardioChek Plus Test System2Cleared 510(K)
- K143750MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System2Cleared 510(K)
- K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System2Cleared 510(K)
- K142336GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System2Cleared 510(K)
- K133584IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K124021ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K131750AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K120615ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE2Cleared 510(K)
- K113636BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)2Cleared 510(K)
- K121706FORA V10 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K122110ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K121654AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION2Cleared 510(K)
- K120921CLEVER CHOICE2Cleared 510(K)
- K120759CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION2Cleared 510(K)
- K113670ELEMENT BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K103230AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION2Cleared 510(K)
- K120448MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL2Cleared 510(K)
- K113547GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL2Cleared 510(K)
- K103116AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K113208GAL-1A BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K103278ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION2Cleared 510(K)
- K102316GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K111371ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K111728EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K101204MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION2Cleared 510(K)
- K103842UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.02Cleared 510(K)
- K101947IVD-GE022Cleared 510(K)
- K103195I-STAT 1 WIRELESS ANALYZER2Cleared 510(K)
- K101741DIATRON PICTUS 4002Cleared 510(K)
- K100525ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 22Cleared 510(K)
- K102037AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS2Cleared 510(K)
- K100405FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K100406FORA V20 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K100187EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT2Cleared 510(K)
- K093506CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-42672Cleared 510(K)
- K093941CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-42652Cleared 510(K)
- K091975INTEGRATED LABORATORY AUTOMATION SOLUTION2Cleared 510(K)
- K082965DS-A BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K092104ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K091814FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE2Cleared 510(K)
- K091102ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS2Cleared 510(K)
- K090109BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD2Cleared 510(K)
- K090043AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F92Cleared 510(K)
- K083570U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K080636DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-1002Cleared 510(K)
- K082482FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-42542Cleared 510(K)
- K083664FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-42452Cleared 510(K)
- K082417GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 731102Cleared 510(K)
- K082121EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS080052Cleared 510(K)
- K081714FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K081609CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-42372Cleared 510(K)
- K073416ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM2Cleared 510(K)
- K073648GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E12Cleared 510(K)
- K070057EASYRA CLINICAL CHEMISTRY ANALYZER2Cleared 510(K)
- K070704TRILOGY ANALYZER2Cleared 510(K)
- K070960NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM2Cleared 510(K)
- K062799GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K063821NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM2Cleared 510(K)
- K062892EUKARE2Cleared 510(K)
- K061431EASYGLUCO, MODEL IGM-0002 G22Cleared 510(K)
- K061528SELFCHECK GLUCO2Cleared 510(K)
- K061992EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS040142Cleared 510(K)
- K060345NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS2Cleared 510(K)
- K053079ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4600012Cleared 510(K)
- K052207ACCUREX GLUCOSE TEST STRIP2Cleared 510(K)
- K052121GEM PREMIER 30002Cleared 510(K)
- K050182Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM2Cleared 510(K)
- K051285GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K043197ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K043245EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K043512EASYGLUCO IGM-0002 G22Cleared 510(K)
- K041881ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4111002Cleared 510(K)
- K040974GLUCOSE OXIDASE, GLUCOSE2Cleared 510(K)
- K041427THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS2Cleared 510(K)
- K041478BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR2Cleared 510(K)
- K042015ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE2Cleared 510(K)
- K033627Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K033055GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS2Cleared 510(K)
- K024014RANDOX RX DAYTONA2Cleared 510(K)
- K031472ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS2Cleared 510(K)
- P990026GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- K031388MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K024347EXPRESS BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K024062ASCENSIA BREEZE BLOOD GLUCOSE METER2Cleared 510(K)
- P990026GLUCOWATCH G2 BIOGRAPHER2PMA Approval
- K023194SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM2Cleared 510(K)
- K022580BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- P990026GLUCOWATCH G2 BIOGRAPHER2PMA Approval
- K022158IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)2Cleared 510(K)
- K021781EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS2Cleared 510(K)
- P990026GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- P990026GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- P990026GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- K021943ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K020935HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 1207062Cleared 510(K)
- K014139DIABETES ASSISTANT SOFTWARE2Cleared 510(K)
- P990026GLUCOWATCH 2 BIOGRAPHER2PMA Approval
- K013342EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.2Cleared 510(K)
- K020232HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- P990026CYGNUS GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- K011953WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA2Cleared 510(K)
- P990026GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- P990026GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- K011479ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K013068BIOSCANNER 20002Cleared 510(K)
- P990026GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- P990026GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- P990026GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- P990026GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- P990026GLUCOWATCH (R) AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- K011233MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 2211002Cleared 510(K)
- K010605ATLAST DATA MANAGEMENT SOFTWARE (DMS)2Cleared 510(K)
- K010520GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS2Cleared 510(K)
- P990026GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER2PMA Approval
- K003346RANDOX GLUCOSE (GOD/PAP)2Cleared 510(K)
- K002688PERSONAL GLUCOSE CONTROL CHARTING SYSTEM2Cleared 510(K)
- K002624GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K002621GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K003257EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION2Cleared 510(K)
- K001441SATURN BLOOD GLUCOSE MONITORING TEST STRIP2Cleared 510(K)
- K001387I-STAT PORTABLE CLINICAL ANALYZER, MODEL 3002Cleared 510(K)
- K001907CAMIT DIABETES MANAGEMENT SOFTWARE2Cleared 510(K)
- K002134ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K001092GENERIC BLOOD GLUCOSE TEST STRIP2Cleared 510(K)
- K001427MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K000583FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K000365ACCU-CHEK ADVANTAGE METER2Cleared 510(K)
- K993837AVL OPTI CRITICAL CARE ANALYZER2Cleared 510(K)
- K993128HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]2Cleared 510(K)
- K993632FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K992988PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM2Cleared 510(K)
- K991480EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP2Cleared 510(K)
- K991754GO GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K990942DUET II GLUCOSE CONTROL MONITORING SYSTEM2Cleared 510(K)
- K990649GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS2Cleared 510(K)
- K983504PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST2Cleared 510(K)
- K991242GLUCOMETER ELITE TEST STRIPS2Cleared 510(K)
- K983344DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL2Cleared 510(K)
- K984261SURESTEP BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K984527IN TOUCH DIABETES MANAGEMENT SOFTWARE2Cleared 510(K)
- K990939FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K984006GLUCOMETER ELITE XL BLOOD GLUCOSE METER2Cleared 510(K)
- K982076AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K982303PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST2Cleared 510(K)
- K980573SENSOREX BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K981183CARESIDE GLUCOSE2Cleared 510(K)
- K974451ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K972669MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON2Cleared 510(K)
- K971653GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM2Cleared 510(K)
- K972473ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK2Cleared 510(K)
- K973140DUET GLUCOSE CONTROL MONITORING SYSTEM2Cleared 510(K)
- K971145GLUCOSITE TEST SYSTEM2Cleared 510(K)
- K972733AVL OMNI ANALYZER2Cleared 510(K)
- K971812PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP2Cleared 510(K)
- K970707ELECT II BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K970556SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K970781LIQUID GLUCOSE (OXIDASE) REAGENT SET2Cleared 510(K)
- K963676PRECISION G BLOOD GLUCOSE TESTING SYSTEM2Cleared 510(K)
- K963544SUPREME II METER2Cleared 510(K)
- K964630GLUCOMETER ELITE BLOOD GLUCOSE METER2Cleared 510(K)
- K963500GLUCOMETER DEX DIABETES CARE SYSTEM2Cleared 510(K)
- K963535SIGMA DIAGNOSTICS GLUCOSE REAGENT2Cleared 510(K)
- K960855PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL2Cleared 510(K)
- K960337AMD HOME HEALTH MONITORING SYSTEM2Cleared 510(K)
- K961985ELECT BLOOD GLUCOSE MONITORIG SYSTEM2Cleared 510(K)
- K955107SAFESTRIP2Cleared 510(K)
- K962295PRECISION QID BLOOD GLUCOSE TEST STRIP2Cleared 510(K)
- K943503CHEMCARD GLUCOSE TEST2Cleared 510(K)
- K960053SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM2Cleared 510(K)
- K960034LXN BLOOD GLUCOSE TEST SYSTEM2Cleared 510(K)
- K961337EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM2Cleared 510(K)
- K955286EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)2Cleared 510(K)
- K944459ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K951457GLUCOCHEK POCKETLAB2Cleared 510(K)
- K952875ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS2Cleared 510(K)
- K950628FIRST CHOICE TEST STRIP2Cleared 510(K)
- K946166FIRST CHOICE(TM) TEST STRIP2Cleared 510(K)
- K952621EML105 ELECTROLYTE METABOLITE ANALYZER2Cleared 510(K)
- K950172WAKO AUTOKIT GLUCOSE2Cleared 510(K)
- K951537GLUCOMETER ELITE M BLOOD GLUCOSE METER2Cleared 510(K)
- K950816ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K952279PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM2Cleared 510(K)
- K950727ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM2Cleared 510(K)
- K942455LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM2Cleared 510(K)
- K945887PRECISION Q I D BLOOD GLUCOSE TEST STRIPS2Cleared 510(K)
- K944195QUICKPRO BLOOD GLUCOSE TESTING SYSTEM2Cleared 510(K)
- K943432HEMOCUE B-GLUCOSE SYSTEM2Cleared 510(K)
- K940215GLUCOCHEK2Cleared 510(K)
- K933694SIGMA GLUCOSE REAGENT2Cleared 510(K)
- K943241DMA GLUCOSE (OXIDASE) PROCEDURE2Cleared 510(K)
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- K931188CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC2Cleared 510(K)
- K925551HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 888072Cleared 510(K)
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- K924475ACCUDATA GLUCOSE TEST STATION2Cleared 510(K)
- K922532IL TEST GLUCOSE, PN 181633-802Cleared 510(K)
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- K913806YSI MODEL 2300 STAT PLUS2Cleared 510(K)
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- K904081GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM2Cleared 510(K)
- K904292ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM2Cleared 510(K)
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- K896144AUTOSCAN, AUTOSTRIP AND AUTOCONTROL2Cleared 510(K)
- K895911ONE TOUCH II METER2Cleared 510(K)
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- K891050STAT CHEM SYSTEM2Cleared 510(K)
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- K871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT2Cleared 510(K)
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- K872505DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS2Cleared 510(K)
- K871586GLUCOCHEK S.C. WITH AUDIO OPTION2Cleared 510(K)
- K873117BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT2Cleared 510(K)
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- K862984UNIDEX GLUCOSE TEST STRIP2Cleared 510(K)
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- K851456ACCU-CHEK II2Cleared 510(K)
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- K841369BETA SCAN DRYSTIX2Cleared 510(K)
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- K842506GLUCOSE-TRINDER-ADDAY KIT2Cleared 510(K)
- K842221WAKO GLUCOSE C2Cleared 510(K)
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- K840962REFLOCHECK-S2Cleared 510(K)
- K840484DIATRON EASYTEST BLOOD GLUCOSE MONI2Cleared 510(K)
- K841055GLUCOSE ENZYMATIC REAGENT SET2Cleared 510(K)
- K834271REFLOCHECK & GLUCOSE TEST STRIP SYS2Cleared 510(K)
- K833257WAKO GLUCOSE C2Cleared 510(K)
- K832691BETA SCAN REAGENT STRIP2Cleared 510(K)
- K833069TDX GLUCOSE2Cleared 510(K)
- K831194GLUCOKEY2Cleared 510(K)
- K832926ENZYMATIC GLUCOSE DETERMINATION2Cleared 510(K)
- K832159UNITIZED ENZYMATIC GLUCOSE TEST SET2Cleared 510(K)
- K831989VISIDEX II REAGENT STRIPS2Cleared 510(K)
- K831634GLUCOSE REAGENT B6360-112Cleared 510(K)
- K831624GLUCOSE REAGENT KITS-B6370-10A2Cleared 510(K)
- K831411GLUCOSE OXIDASE/PEROXIDASE TEST2Cleared 510(K)
- K823474ENZYMATIC GLUCOSE DETERMINATION2Cleared 510(K)
- K822976HYPOCOUNT A2Cleared 510(K)
- K822958LANCER MSH GLUCOSE DIAG. KIT2Cleared 510(K)
- K822699GLUCOSCAN METER MODEL II2Cleared 510(K)
- K822486HOME BLOOD GLUCOSE MONITOR2Cleared 510(K)
- K822697GLUCOSCAN TEST STRIPS2Cleared 510(K)
- K821204GLUCOSE(ENZYMATIC) REAGENT SET2Cleared 510(K)
- K821192YSI #24 & 24M GLUCOSE ANALYZERS2Cleared 510(K)
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- K821091ACCUCHEK BG.2Cleared 510(K)
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- K813370ELECTROLYTE GEL2Cleared 510(K)
- K812866ASTRA REAGENT CONCENTRATE SYSTEM2Cleared 510(K)
- K813168LIQUIZYME GLUCOSE REAGENT2Cleared 510(K)
- K812258ACR ENZYMATIC GLUCOSE OXIDASE2Cleared 510(K)
- K811165GLUCOSE OXIDASE RATE REAGENT2Cleared 510(K)
- K811882KING DIAGNOSTICS GLUCOSE TEST2Cleared 510(K)
- K811592LIQUIZYME SINGLE SOLUTION GLUCOSE REAG2Cleared 510(K)
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- K811074GLUCOSE REAGENT-ENZYMATIC-COLOR 5002Cleared 510(K)
- K810993GLUCOSCAN TEST STRIPS2Cleared 510(K)
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- K801897GLUCOSE DIAGNOSTIC REAGENT2Cleared 510(K)
- K801600GLUCOSE (TRINDER) REAGENT2Cleared 510(K)
- K801663SERALYZER GLUCOSE REAGENT STRIPS2Cleared 510(K)
- K800687REAGENT FOR DETERM. GLUCOSE IN H/SERUM2Cleared 510(K)
- K801071LANCER GLUCOSE RATE REAGENT KIT2Cleared 510(K)
- K800589GLUCOSE OXIDASE REAGENT2Cleared 510(K)
- K800200LINEAR ENZYMATIC GLUCOSE SYSTEM2Cleared 510(K)
- K800070GLUCOSE OXIDASE REAGENT KIT2Cleared 510(K)
- K792534NEOCHROME II GLUCOSE, #40442Cleared 510(K)
- K792398ELVI GLUCOSE2Cleared 510(K)
- K791989TECHNICON C202 SYSTEM2Cleared 510(K)
- K791869GLUCOSE OXIDASE (FRINDER) KIT2Cleared 510(K)
- K791669GLUCOSE OXIDASE REAGENT SET2Cleared 510(K)
- K791685GLUCOSE REAGENT2Cleared 510(K)
- K791066GLUCOSE GOD-PAP TRINDER METHOD TEST KIT2Cleared 510(K)
- K781945GLUCOSE OXIDASE REAGENT2Cleared 510(K)
- K781342GLUCOSE TEST2Cleared 510(K)
- K781307GLUCOSE DETERM. KIT2Cleared 510(K)
- K781075STATTEK-GLUCOSE LOW LEVEL2Cleared 510(K)
- K780393BIOSTATOR GLUCOSE ANALYZER2Cleared 510(K)
- K780512AUTO/STAT KIT2Cleared 510(K)
- K772308AUTOZYME GLUCOSE OXIDASE (TRINDER)2Cleared 510(K)
- K780093GLUCOSE REAGENT FOR GLUCOSE ANALYZER2Cleared 510(K)
- K771754GLUCOSE REAGENT FOR GLUC. ANALYZER2Cleared 510(K)
- K771471MULTISTAT III GLUCOSE TEST2Cleared 510(K)
- K771059DIAG. OZYRATE GLUCOSE REAG. SET2Cleared 510(K)
- K771000TRENDAR2Cleared 510(K)
- K771001STATZYME GLUCOSE2Cleared 510(K)
- K770317GLUCOSE TRINDER, ENZYMATIC2Cleared 510(K)
- K770200GO/HPO-GLUCOSE REAGENT (TRINDER)2Cleared 510(K)
- K761148REFLOMAT/REFLOTEST SYSTEM2Cleared 510(K)
- K761060GLUCOSE ANALYZER 22Cleared 510(K)
- K761181GLUCOSE OXIDASE REAGENT SYSTEM2Cleared 510(K)
- K761154GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ2Cleared 510(K)
- K761153GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE2Cleared 510(K)
- K760347SET, TRINDER GLUCOSE2Cleared 510(K)
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- CGDFerricyanide, Glucose2Product Code
- CGEOrthotoluidine, Glucose2Product Code
- CGFRadioimmunoassay, Estrone1Product Code
- CGHElectrophoretic, Globulin1Product Code
- CGIRadioimmunoassay, Estriol1Product Code
- CGJRadioimmunoassay, Follicle-Stimulating Hormone1Product Code
- CGLElectrode, Ion Based, Enzymatic, Creatinine2Product Code
- CGNAcid, Folic, Radioimmunoassay2Product Code
- CGOLieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol1Product Code
- CGRRadioimmunoassay, Cortisol2Product Code
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes2Product Code
- CGTRadioimmunoassay, Cyclic Gmp2Product Code
- CGXAlkaline Picrate, Colorimetry, Creatinine2Product Code
- CGZElectrode, Ion-Specific, Chloride2Product Code
- CHCTitrimetric Permanganate And Bromophenol Blue, Calcium2Product Code
- CHDAcid, Ferric Ion-Sulfuric, Cholesterol1Product Code
- CHERadioimmunoassay, Corticoids1Product Code
- CHGAcid, Phosphoric-Tungstic (Spectrophotometric), Chloride2Product Code
- CHHEnzymatic Esterase--Oxidase, Cholesterol1Product Code
- CHILipase-Esterase, Enzymatic, Photometric, Lipase1Product Code
- CHJMercuric Thiocyanate, Colorimetry, Chloride2Product Code
- CHKMercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride2Product Code
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph2Product Code
- CHMRadioimmunoassay, Total Estrogens In Pregnancy1Product Code
- CHORadioimmunoassay, Cyclic Amp2Product Code
- CHPRadioimmunoassay, Estradiol1Product Code
- CHQChromatographic/Fluorometric Method, Catecholamines1Product Code
- CHRTitrimetric Phenol Red, Carbon-Dioxide2Product Code
- CHSCoulometric Method, Carbon-Dioxide2Product Code
- CHTElectrophoretic Method, Catecholamines1Product Code
- CHWTitrimetric With Edta And Indicator, Calcium2Product Code
- CHZDi (O-Hydroxyphenylimine) Ethane, Calcium2Product Code
- CIAMethylthymol Blue, Calcium2Product Code
- CIBRadioimmunoassay, Angiotensin I And Renin2Product Code
- CICCresolphthalein Complexone, Calcium2Product Code
- CIDAlizarin Sulfonate, Calcium2Product Code
- CIEVolumetric/Manometric, Carbon-Dioxide2Product Code
- CIFVanillin Pyruvate, Ast/Sgot2Product Code
- CIGDiazo Colorimetry, Bilirubin2Product Code
- CIJSaccharogenic, Amylase2Product Code
- CIKRadial Diffusion, Amylase2Product Code
- CILCresol Red Colorimetry, Carbon-Dioxide2Product Code
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes2Product Code
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CIQDiazo, Ast/Sgot2Product Code
- CISHydrazone Colorimetry, Ast/Sgot2Product Code
- CITNadh Oxidation/Nad Reduction, Ast/Sgot2Product Code
- CIWStarch-Dye Bound Polymer, Amylase2Product Code
- CIXBromcresol Green Dye-Binding, Albumin2Product Code
- CIYRadioimmunoassay, Androsterone1Product Code
- CIZRadioimmunoassay, Androstenedione1Product Code
- CJAAmyloclastic, Amylase2Product Code
- CJBChromatographic Separation/Radioimmunoassay, Aldosterone2Product Code
- CJCFructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase1Product Code
- CJDNitrosalicylate Reduction, Amylase2Product Code
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJFTetrabromophenolphthalein, Albumin2Product Code
- CJGTetrabromo-M-Cresolsulfonphthalein, Albumin2Product Code
- CJHThymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJIDisodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJJDiazo, Alt/Sgpt1Product Code
- CJKPhenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJLBeta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJMRadioimmunoassay, Aldosterone2Product Code
- CJNAcid Phosphatase, Nitrophenylphosphate2Product Code
- CJOAlpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJQRadial Immunodiffusion, Albumin2Product Code
- CJRAcid Phosphatase, Thymol Blue Monophosphate2Product Code
- CJTHydrazone Colorimetry, Aldolase1Product Code
- CJWBromcresol Purple Dye-Binding, Albumin2Product Code
- CJXAcid Phosphatase, Disodium Phenylphosphate2Product Code
- CJYAzo Dye, Calcium2Product Code
- CJZAcid, Hydroxyazobenzene-Benzoic, Albumin2Product Code
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt1Product Code
- CKBAcid Phosphatase, Naphthyl Phosphate2Product Code
- CKCVanillin Pyruvate, Alt/Sgpt1Product Code
- CKDHydrazone Colorimetry, Alt/Sgpt1Product Code
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate2Product Code
- CKFPhenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CKGRadioimmunoassay, Acth2Product Code
- CKHAcid Phosphatase, Beta Glycerophosphate2Product Code
- DHASystem, Test, Human Chorionic Gonadotropin2Product Code
- GIMTubes, Vacuum Sample, With Anticoagulant2Product Code
- GJETray, Blood Collection2Product Code
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited2Product Code
- JFJCatalytic Methods, Amylase2Product Code
- JFLPh Rate Measurement, Carbon-Dioxide2Product Code
- JFMEnzymatic Method, Bilirubin2Product Code
- JFNAtomic Absorption, Calcium2Product Code
- JFOFluorometric, Calcium2Product Code
- JFPElectrode, Ion Specific, Calcium2Product Code
- JFSCoulometric, Chloride2Product Code
- JFTFluorometric, Cortisol2Product Code
- JFYEnzymatic Method, Creatinine2Product Code
- JGCTryptophan Measurement (Colorimetric), Globulin1Product Code
- JGDNephelometric Method, Globulin1Product Code
- JGETurbidimetric Method, Globulin1Product Code
- JGFDifferential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes2Product Code
- JGGL-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase1Product Code
- JGIAtomic Absorption, Magnesium1Product Code
- JGJPhotometric Method, Magnesium1Product Code
- JGKFerric Chloride, Phenylketones (Urinary, Non-Quant.)1Product Code
- JGMFlame Photometry, Potassium2Product Code
- JGPLowry (Colorimetric), Total Protein2Product Code
- JGQTurbidimetric, Total Protein2Product Code
- JGRRefractometric, Total Protein2Product Code
- JGSElectrode, Ion Specific, Sodium2Product Code
- JGTFlame Photometry, Sodium2Product Code
- JGWFluorometric Method, Triglycerides1Product Code
- JGXTurbidimetric Method, Triglycerides1Product Code
- JGYColorimetric Method, Triglycerides1Product Code
- JGZO-Phthalaldehyde, Urea Nitrogen2Product Code
- JHAAcid, Uric, Uricase (Gasometric)1Product Code
- JHCAcid, Uric, Uricase (Oxygen Rate)1Product Code
- JHDFluorometric Method, 17-Hydroxycorticosteroids1Product Code
- JHERadioassay, 17-Hydroxycorticosteroids1Product Code
- JHFColorimetric Method, Lecithin/Sphingomyelin Ratio2Product Code
- JHGChromatographic Separation, Lecithin/Sphingomyelin Ratio2Product Code
- JHHElectrophoretic Method, Lecithin/Sphingomyelin Ratio2Product Code
- JHIVisual, Pregnancy Hcg, Prescription Use2Product Code
- JHJAgglutination Method, Human Chorionic Gonadotropin2Product Code
- JHLMicrodensitometry Method, Lipoproteins1Product Code
- JHMColorimetric Method, Lipoproteins1Product Code
- JHNTurbidimetric Method, Lipoproteins1Product Code
- JHOElectrophoretic Separation, Lipoproteins1Product Code
- JHPRadial Immunodiffusion, Lipoproteins1Product Code
- JHQNephelometric Method, Lipoproteins1Product Code
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes2Product Code
- JHTChromatographic Separation, Cpk Isoenzymes2Product Code
- JHWU.V. Method, Cpk Isoenzymes2Product Code
- JHXFluorometric Method, Cpk Or Isoenzymes2Product Code
- JHYColorimetric Method, Cpk Or Isoenzymes2Product Code
- JIAEnzymatic Methods, Galactose1Product Code
- JIBU.V. Method, Galactose1Product Code
- JICColorimetric Method, Galactose1Product Code
- JIDPhotometric Method, Ammonia1Product Code
- JIEMethod, Ion-Exchange, Ammonia1Product Code
- JIFEnzymatic Method, Ammonia1Product Code
- JIGElectrode, Ion-Specific Method, Ammonia1Product Code
- JIJWet Ash Method, Protein-Bound Iodine1Product Code
- JIKDry Ash Method, Protein-Bound Iodine1Product Code
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)2Product Code
- JIMMethod, Metallic Reduction, Glucose (Urinary, Non-Quantitative)2Product Code
- JINNitroprusside, Ketones (Urinary, Non-Quant.)1Product Code
- JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)1Product Code
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)1Product Code
- JISCalibrator, Primary2Product Code
- JITCalibrator, Secondary2Product Code
- JIWCalibrator, Surrogate2Product Code
- JIXCalibrator, Multi-Analyte Mixture2Product Code
- JIYPhotometric Method, Iron (Non-Heme)1Product Code
- JIZAtomic Absorption, Iron (Non-Heme)1Product Code
- JJARadio-Labeled Iron Method, Iron (Non-Heme)1Product Code
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)1Product Code
- JJRElectrolyte Controls (Assayed And Unassayed)1Product Code
- JJSControls For Blood-Gases, (Assayed And Unassayed)1Product Code
- JJTEnzyme Controls (Assayed And Unassayed)1Product Code
- JJWUrinalysis Controls (Assayed And Unassayed)1Product Code
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1Product Code
- 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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- 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
CardioChek Plus Test System, CardioChek Home Test System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K162282
- 510(k) Type
- Special
- Applicant
- Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/22/2016
- Days to Decision
- 129 days
- Submission Type
- Summary