Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- GKKCyanomethemoglobin2Product Code
- GIQHemoglobin S2Product Code
- GISTest, Fibrinogen2Product Code
- GITReagent & Control, Partial Thromboplastin Time2Product Code
- GJATest, Thrombin Time2Product Code
- GJBThrombin2Product Code
- GJCAssay, Sulfhemoglobin2Product Code
- GJSTest, Time, Prothrombin2Product Code
- GJTPlasma, Coagulation Factor Deficient2Product Code
- GJZCyanomethemoglobin Reagent And Standard Solution2Product Code
- GKAAbnormal Hemoglobin Quantitation2Product Code
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control2Product Code
- DARFibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control2Product Code
- DATFibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control2Product Code
- DAXFibrinogen And Split Products, Fitc, Antigen, Antiserum, Control2Product Code
- DAZFibrinogen And Split Products, Antigen, Antiserum, Control2Product Code
- DDQAntigen, Antiserum, Control, Antithrombin Iii2Product Code
- GFKFibrinogen Determination Standards And Controls2Product Code
- GFOActivated Partial Thromboplastin2Product Code
- GFTProtamine Sulphate2Product Code
- GFXFibrinogen Standard2Product Code
- GGFAcid Hematin2Product Code
- GGOReagent, Thromboplastin And Control2Product Code
- GGPTest, Qualitative And Quantitative Factor Deficiency2Product Code
- GGQTest, Prothrombin Consumption2Product Code
- GGTAssay, Erythropoietin2Product Code
- GGWTest, Time, Partial Thromboplastin2Product Code
- GGZOxyhemoglobin2Product Code
- GHAHemoglobin, Alkali Resistant2Product Code
- GHDTest, Leukocyte Alkaline Phosphatase1Product Code
- GHHFibrin Split Products2Product Code
- GHMTest, Sickle Cell2Product Code
- GHQStain, Fetal Hemoglobin2Product Code
- GHSAssay, Carboxyhemoglobin2Product Code
- GIGHemoglobinometer2Product Code
- GIIGlutathione, Red-Cell2Product Code
- GILPlasma, Fibrinogen Control2Product Code
- GKQTest, Thromboplastin Generation1Product Code
- GLYOximeter To Measure Hemoglobin2Product Code
- JBBSolubility, Hemoglobin, Abnormal2Product Code
- JBDSystem, Analysis, Electrophoretic Hemoglobin2Product Code
- JBECell Enzymes (Erythrocytic And Leukocytic)2Product Code
- JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening2Product Code
- JBGGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot2Product Code
- JBHGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod2Product Code
- JBIGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition2Product Code
- JBJGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction2Product Code
- JBKGlucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic2Product Code
- JBLGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative2Product Code
- JBMGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis2Product Code
- JBNFibrin Monomer Paracoagulation2Product Code
- JBOTest, Euglobulin Lysis2Product Code
- JBPActivated Whole Blood Clotting Time2Product Code
- JBQAntithrombin Iii Quantitation2Product Code
- JBRTest, Heparin Neutralization2Product Code
- JCJAlkaline Phosphatase1Product Code
- JCMControl, Hemoglobin, Abnormal2Product Code
- JLMIsoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase2Product Code
- JMBVisual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase2Product Code
- JMCNadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase2Product Code
- JMHFluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase2Product Code
- JPBHemoglobin M2Product Code
- JPCHemoglobin F Quantitation2Product Code
- JPDHemoglobin A2 Quantitation2Product Code
- JPEAntithrombin Iii, Two Stage Clotting Time Assay2Product Code
- JPFProthrombin-Proconvertin And Thrombotest2Product Code
- JWRAtp Release (Luminescence)1Product Code
- KFFAssay, Heparin2Product Code
- KHFAdenine Nucleotide Quantitation1Product Code
- KHGWhole Blood Hemoglobin Determination2Product Code
- KQEAssay, Erythrocytic Glucose-6-Phosphate Dehydrogenase2Product Code
- KQFAssay, Glutathione Reductase2Product Code
- KQIAssay, Fetal Hemoglobin2Product Code
- KQJSystem, Fibrinogen Determination2Product Code
- LCOPlatelet Factor 4 Radioimmunoassay2Product Code
- LCPAssay, Glycosylated Hemoglobin2Product Code
- K221326Nova Allegro HbA1c Assay, Nova Allegro Analyzer2Cleared 510(K)
- K231465Q-Pad Test System2Cleared 510(K)
- K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer2Cleared 510(K)
- K192987Aina HbA1c Monitoring System 22Cleared 510(K)
- K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit2Cleared 510(K)
- K183230OneDraw A1C Test System2Cleared 510(K)
- K181915PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit2Cleared 510(K)
- K180509Quo-Test A1c System2Cleared 510(K)
- K173127skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)2Cleared 510(K)
- K170623ACE Hemoglobin A1c (HbA1c) Reagent2Cleared 510(K)
- K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzer2Cleared 510(K)
- K170147Lucica Glycated Albumin-L2Cleared 510(K)
- K163633cobas HbA1c Test, cobas b 101 system2Cleared 510(K)
- K161533A1C EZ Glycohemoglobin Analysis System2Cleared 510(K)
- K162281CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)2Cleared 510(K)
- K160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set2Cleared 510(K)
- K142664URight Hemoglobin A1c system, FORA A1c System2Cleared 510(K)
- K140827SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set2Cleared 510(K)
- K151809Alere Afinion HbA1c, Alere Afinion AS100 Analyzer2Cleared 510(K)
- K141944HOME ACCESS AIC TEST2Cleared 510(K)
- K142789A1c iGear System2Cleared 510(K)
- K133803DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT2Cleared 510(K)
- K141750HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM2Cleared 510(K)
- K140829UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT2Cleared 510(K)
- K140801VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM2Cleared 510(K)
- K130014A1C GEAR SYSTEM2Cleared 510(K)
- K133344MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS2Cleared 510(K)
- K131307ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR2Cleared 510(K)
- K130990VARIANT(TM) II TURBO HBA1C KIT - 2.02Cleared 510(K)
- K130860VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE2Cleared 510(K)
- K121842ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C2Cleared 510(K)
- K122101CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C2Cleared 510(K)
- K122472VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM2Cleared 510(K)
- K120199GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY2Cleared 510(K)
- K111128LABONACHECK A1C2Cleared 510(K)
- K121492UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT2Cleared 510(K)
- K121366HEMOCUE HBA1C 5012Cleared 510(K)
- K113437ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT2Cleared 510(K)
- K120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL2Cleared 510(K)
- K110313TINA-QUANT HBA1C GEN.22Cleared 510(K)
- K112015PREMIER HB9210 HBA1C ANALYZER2Cleared 510(K)
- K110934ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY2Cleared 510(K)
- K093548AVIE A1C TEST SYSTEM2Cleared 510(K)
- K100547ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL2Cleared 510(K)
- K110188DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT2Cleared 510(K)
- K102510DIMENSIONS HB1C KIT, MODEL DF105A2Cleared 510(K)
- K110056AFINION ANALYZER2Cleared 510(K)
- K102045DIMENSION VISA HBA1C, MODEL K3105A2Cleared 510(K)
- K102914TQ HBA1C GEN32Cleared 510(K)
- K100304ST AIA PACK HBA1C2Cleared 510(K)
- K082275CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-00232Cleared 510(K)
- K091711S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC00232Cleared 510(K)
- K090699VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-27302Cleared 510(K)
- K091400MODIFICATION TO AVIE A1C TEST SYSTEM2Cleared 510(K)
- K090413A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC2Cleared 510(K)
- K081269AVIE A1C TEST SYSTEM2Cleared 510(K)
- K081895ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS2Cleared 510(K)
- K073309ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT2Cleared 510(K)
- K071132G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G82Cleared 510(K)
- K080618DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID2Cleared 510(K)
- K072714TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM2Cleared 510(K)
- K072686AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS2Cleared 510(K)
- K062658PRIMUS A1CARE ASSAY2Cleared 510(K)
- K071466DCA VANTAGE, MODEL 50752Cleared 510(K)
- K070819VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,2Cleared 510(K)
- K070452VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU2Cleared 510(K)
- K063306ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-722Cleared 510(K)
- K070734MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON2Cleared 510(K)
- K063209HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL2Cleared 510(K)
- K063643MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM2Cleared 510(K)
- K063400VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.02Cleared 510(K)
- K060650VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 17022Cleared 510(K)
- K053411DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS2Cleared 510(K)
- K060001D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM2Cleared 510(K)
- K052464TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST2Cleared 510(K)
- K051200HEMOGLOBIN A1C REAGENT SET2Cleared 510(K)
- K050574AFINION HBALC2Cleared 510(K)
- K050178HBA1C ENZYMATIC ASSAY2Cleared 510(K)
- K051321INVIEW2Cleared 510(K)
- K042459SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT2Cleared 510(K)
- K042193DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT2Cleared 510(K)
- K031296LIQUI-HEME GLYCO A1C ASSAY2Cleared 510(K)
- K041764THE VITROS 5,1 FS CHEMISTRY SYSTEM2Cleared 510(K)
- K041635G5 I HBA1C TEST, G5 II HBA1C TEST2Cleared 510(K)
- K041444BIO-RAD D-10 DUAL PROGRAM2Cleared 510(K)
- K040872VARIANT II HEMOGLOBIN A1C2Cleared 510(K)
- K033674MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS2Cleared 510(K)
- K033847A1CNOW FOR HOME AND PROFESSIONAL USE2Cleared 510(K)
- K031380OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)2Cleared 510(K)
- K031042ATAC HEMOGLOBIN A1C REAGENT KIT2Cleared 510(K)
- K030553ARKIT HBA1C2Cleared 510(K)
- K031043D-10 HEMOGLOBIN A1C2Cleared 510(K)
- K031539HEMOGLOBIN A1C REAGENT SET2Cleared 510(K)
- K023654GLYCA-DIRECT FRUCTOSAMINE2Cleared 510(K)
- K023763RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS2Cleared 510(K)
- K022661A1CNOW FOR HOME USE2Cleared 510(K)
- K021897RANDOX HAEMOGLOBIN A1C2Cleared 510(K)
- K021484HEMOGLOBIN A1C CONTROL2Cleared 510(K)
- K020532POLYMEDCO HBA1C TEST2Cleared 510(K)
- K020234A1CNOW FOR RX HOME USE2Cleared 510(K)
- K020235A1CNOW FOR PROFESSIONAL USE2Cleared 510(K)
- K013465ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT2Cleared 510(K)
- K011852DIMENSION HAIC ASSAY, MODEL DF1052Cleared 510(K)
- K011933GLYCOSAL II HBA 1C TEST2Cleared 510(K)
- K012410INFINITY HBA KIT, MODELS 537-A, 537-B2Cleared 510(K)
- K012525THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/2352Cleared 510(K)
- K011434G7 AUTOMATED HPLC ANALYZER2Cleared 510(K)
- K010748SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT2Cleared 510(K)
- K003280VARIANT II TOTAL GHB2Cleared 510(K)
- K003120MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C2Cleared 510(K)
- K000885DRX HBA1C - FOR PRESCRIPTION HOME USE2Cleared 510(K)
- K001392GLYCOSAL HBA1C TEST2Cleared 510(K)
- K000887DRX HBA1C2Cleared 510(K)
- K992085ABBOTT IMX GLYCATED HEMOGLOBIN II2Cleared 510(K)
- K993131NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY2Cleared 510(K)
- K000239GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL2Cleared 510(K)
- K994045PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 22Cleared 510(K)
- K993590FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET2Cleared 510(K)
- K990899HEMOCHEK-A1C SAMPLE COLLECTION KIT2Cleared 510(K)
- K991246FRUCTOSAMINE, MODEL FR 106-012Cleared 510(K)
- K991850SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC2Cleared 510(K)
- K992921PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II2Cleared 510(K)
- K991483ABBOTT ARCHITECT GLYCATED HEMOGLOBIN2Cleared 510(K)
- K990992INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC2Cleared 510(K)
- K984529HEMOCHEK SAMPLE COLLECTION KIT2Cleared 510(K)
- K984268VARIANT II HEMOGLOBIN A1C PROGRAM2Cleared 510(K)
- K983172ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT2Cleared 510(K)
- K983726GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL2Cleared 510(K)
- K983253PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT2Cleared 510(K)
- K980888GLYCACOR2Cleared 510(K)
- K973365AIC - CHEK (HBAIC-I)2Cleared 510(K)
- K974491ACCU-CHEK A1C HEMOGLOBIN TEST2Cleared 510(K)
- K973696SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT2Cleared 510(K)
- K972265A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER2Cleared 510(K)
- K971919EZCHEK/HBA BLOOD COLLECTION KIT2Cleared 510(K)
- K962597LXN FRUCTOSAMINE TEST SYSTEM2Cleared 510(K)
- K963844HYDRAGEL 15 HB A1C KIT2Cleared 510(K)
- K961674ROCHE UNIMATE FRUCTOSAMINE REAGENT2Cleared 510(K)
- K955087HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS2Cleared 510(K)
- K952337ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P2Cleared 510(K)
- K946274COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN2Cleared 510(K)
- K936285ABBOTT VISION GLYCATED HB, MODIFICATION2Cleared 510(K)
- K951361DCA 2000 SYSTEM FOR HEMOGLOBIN A1C2Cleared 510(K)
- K941616VARIANT TOTAL GHB PROGRAM2Cleared 510(K)
- K934070TINA-QUANT HEMOGLOBIN A1C2Cleared 510(K)
- K942009PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY2Cleared 510(K)
- K940971AMES DCA 2000 HEMOGLOBIN ALC CONTROLS2Cleared 510(K)
- K935613RADIAS MONOCLONAL HBA 1C ASSAY2Cleared 510(K)
- K936204GLYCATED HEMOGLOBIN CALIBRATORS2Cleared 510(K)
- K940143GLYCATED HEMOGLOBIN CONTROLS2Cleared 510(K)
- K931183GLYCOHEMOGLOBIN2Cleared 510(K)
- K933287745 GLYCOMAT2Cleared 510(K)
- K930823PROTEIN-BOUND GLUCOSE ASSAYN KIT2Cleared 510(K)
- K926469VARIANT(TM) HEMOGLOBIN A 1C PROGRAM2Cleared 510(K)
- K925204BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED2Cleared 510(K)
- K921831IMX(R) GLYCATED HEMOGLOBIN2Cleared 510(K)
- K920820MODIFICATION COLUMNMATE2Cleared 510(K)
- K920397REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT2Cleared 510(K)
- K920449POINTE 750 GLYCOMETER2Cleared 510(K)
- K920198GLYCOMAT HAEMOGLOBIN ANALYSER2Cleared 510(K)
- K921676COLUMNMATE II2Cleared 510(K)
- K921305GLYCO-TEK AFFINITY COLUMN KIT2Cleared 510(K)
- K913614FRUCTOSAMINE ABG21 TEST SYSTEM2Cleared 510(K)
- K912748BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT2Cleared 510(K)
- K905709BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT2Cleared 510(K)
- K911625AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM2Cleared 510(K)
- K904027ABBOTT VISION(TM) GLYCATED HB2Cleared 510(K)
- K905513GLYC-AFFIN(TM)-GA2Cleared 510(K)
- K904814GLYC-AFFIN GP2Cleared 510(K)
- K896830OPTIMATE HEMOGLOBIN A1C2Cleared 510(K)
- K902455ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)2Cleared 510(K)
- K902457ABNORMAL GLYCOHEMOGLOBIN CONTROL2Cleared 510(K)
- K896582DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)2Cleared 510(K)
- K901414COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 15812Cleared 510(K)
- K900718ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY2Cleared 510(K)
- K896335CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR2Cleared 510(K)
- K896334CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER2Cleared 510(K)
- K895661GLYCOTEST II GLYHB ASSAY KIT2Cleared 510(K)
- K893453GLYCABEN2Cleared 510(K)
- K893224REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #32072Cleared 510(K)
- K891235PRIMUS MODEL CLC 3302Cleared 510(K)
- K884184SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE2Cleared 510(K)
- K884315LABILE LYSING REAGENT2Cleared 510(K)
- K880673GHB SAMPLE PAPER2Cleared 510(K)
- K881863REP GLYCO SYSTEM2Cleared 510(K)
- K874749BINAX EQUATE GLYCOHEMOGLOBIN2Cleared 510(K)
- K882222DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY2Cleared 510(K)
- K882051BIO-RAD HEMOGLOBIN DETECTOR2Cleared 510(K)
- K880698TITAN GEL-PC GLYCO-HEME(TM) SYSTEM2Cleared 510(K)
- K873428GLYCO-PROBE GSP2Cleared 510(K)
- K875354UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM2Cleared 510(K)
- K854010FRUCTOSAMINE TEST (ROCHE)2Cleared 510(K)
- K872852EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST2Cleared 510(K)
- K871679FOCUS-GHB2Cleared 510(K)
- K871388MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER2Cleared 510(K)
- K864643GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT2Cleared 510(K)
- K862371HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)2Cleared 510(K)
- K861697SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)2Cleared 510(K)
- K862556SANDARE GLYCOHEMOGLOBIN PROCEDURE2Cleared 510(K)
- K860572GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET2Cleared 510(K)
- K852986GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN2Cleared 510(K)
- K851636DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM2Cleared 510(K)
- K852111GLYCO-CHECK2Cleared 510(K)
- K842689GLYCO-TEK AFFINITY COLUMN2Cleared 510(K)
- K834294ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB2Cleared 510(K)
- K833772AUTO AIC ANALYZER SYSTEM2Cleared 510(K)
- K833805GLYCOGLOBIN KIT2Cleared 510(K)
- K833356GLYCO-JE,E CPMTRP;-NORMAL/ABNORMAL2Cleared 510(K)
- K832775A-GENT GLYCOSYLATED HEMOGLOBIN2Cleared 510(K)
- K832087TITAN GEL GLYCO-HEME SYSTEM2Cleared 510(K)
- K831837CLINOVATIVE II DIAGNOSTIC KIT2Cleared 510(K)
- K831478LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN2Cleared 510(K)
- K830935HEMOGLOBIN ALC BY COLUMN TEST2Cleared 510(K)
- K823869GLYCO HB QUIK COLUMN PROCEDURE2Cleared 510(K)
- K822867GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY2Cleared 510(K)
- K822977HEMOGLOBIN ALC BY COLUMN TEST2Cleared 510(K)
- K821360GLYCO-GEL TEST KIT2Cleared 510(K)
- K820279GLYCO-GEL TEST KIT2Cleared 510(K)
- K820076GLYCO-SEP REAGENT TEST SET2Cleared 510(K)
- K811567ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S2Cleared 510(K)
- K810958GLYCOHEMOGLOBIN2Cleared 510(K)
- K812242CORDISNHYPERION HEMOGLOBIN A1 TEST SYS2Cleared 510(K)
- K811710BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST2Cleared 510(K)
- K811000ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL2Cleared 510(K)
- K810714LANCER GLYCOSYLATED HEMOGLOBIN ASSAY2Cleared 510(K)
- K810638LANCER GLYCOSYLATED HEMOGLOBIN2Cleared 510(K)
- K803186NORMAL AND ELEVATED CONTROL FOR GLYCO.2Cleared 510(K)
- K802832SANDARE GLYCOHEMOGLOBIN PROCEDURE2Cleared 510(K)
- K802721GLYCOHEMOGLOBIN IN WHOLE BLOOD2Cleared 510(K)
- K802432GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.2Cleared 510(K)
- K802233GLYCOSYLATED HEMOGLOBIN-SMC COLUMN2Cleared 510(K)
- K800857HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH2Cleared 510(K)
- K801561GLYCOSYLATED HEMOGLOBIN KIT2Cleared 510(K)
- K801422SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.2Cleared 510(K)
- K801289LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT2Cleared 510(K)
- K800794FAST HEMOGLOBIN CONTROL-LYOPHILIZED2Cleared 510(K)
- K792086GLYCO-SPIN2Cleared 510(K)
- K791777CORNING GLYCOSYLATED HEMOGLOBIN SET2Cleared 510(K)
- K791642A-GENT GLYCOSPEC2Cleared 510(K)
- K791365FAST FLOW #603102Cleared 510(K)
- K791428GLUCOHEMOGLOBIN CONTROL2Cleared 510(K)
- K791135LYOPHILIZED G-HB QUIK COLUMN CONTROL2Cleared 510(K)
- K791103LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT2Cleared 510(K)
- K790583QUIK COLUMN METHODOLOGY2Cleared 510(K)
- K790046G-HB QUIK COLUMN CONTROL2Cleared 510(K)
- K781948COLUMN TEST, HEMOGLOBIN A2Cleared 510(K)
- K781851HEMOGLOBIN, TESTING SYSTEM2Cleared 510(K)
- K780819GLYCOHEMOGLOBIN-SKREEN TEST KIT2Cleared 510(K)
- K780573TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN2Cleared 510(K)
- LGLAssay, Bart'S, Hemoglobin2Product Code
- LGOTest, Leukocyte Typing1Product Code
- LIMTest, Screening, For D Positive Fetal Rbc'S2Product Code
- LJXTest, Urine Leukocyte1Product Code
- LKZRed-Cell Count By Photometry2Product Code
- MIFProthrombin Fragment 1.22Product Code
- MLLHemoglobin C (Abnormal Hemoglobin Variant)2Product Code
- NOZAssay, 1,5-Anhydroglucitol (15ag)2Product Code
- ODVVitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System2Product Code
- OMMTest 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr2Product Code
- PWDFlow Cytometric Test System For Hematopoietic Neoplasms2Product Code
- QGUHemoglobin For Donor Testing2Product Code
- QLUAnti-Factor Xa Activity Test System, Apixaban2Product Code
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- 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
SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
- Page Type
- Cleared 510(K)
- 510(k) Number
- K140827
- 510(k) Type
- Traditional
- Applicant
- SD Biosensor, Inc.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/30/2015
- Days to Decision
- 547 days
- Submission Type
- Summary