| Nova Allegro HbA1c Assay, Nova Allegro Analyzer (K221326) | Nova Biomedical Corporation | 2024-11-22 |
| Q-Pad Test System (K231465) | Qurasense | 2023-12-06 |
| Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer (K214117) | Abbott Diagnostics Technologies AS | 2023-09-27 |
| Aina HbA1c Monitoring System 2 (K192987) | Jana Care, Inc. | 2020-03-26 |
| PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (K192369) | Ixensor Co, Ltd. | 2019-10-29 |
| OneDraw A1C Test System (K183230) | Drawbridge Health, Inc. | 2019-08-15 |
| PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (K181915) | Ixensor Co, Ltd. | 2019-04-12 |
| Quo-Test A1c System (K180509) | Ekf-Diagnostic GmbH | 2019-02-16 |
| skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) (K173127) | Skyla Corporation H.S.P.B | 2018-09-25 |
| ACE Hemoglobin A1c (HbA1c) Reagent (K170623) | Alfa Wassermann Diagnostic Technologies, LLC | 2018-02-27 |
| Alere Afinion HbA1c and ACR on Afinion 2 analyzer (K171650) | Abbott Rapid Diagnostics | 2017-11-21 |
| Lucica Glycated Albumin-L (K170147) | Asahi Kasei Pharma Corporation | 2017-10-12 |
| cobas HbA1c Test, cobas b 101 system (K163633) | Roche Diagnostics Operations | 2017-07-28 |
| A1C EZ Glycohemoglobin Analysis System (K161533) | Biohermes Co., Ltd. | 2017-06-16 |
| CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) (K162281) | Sebia | 2017-02-17 |
| Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set (K160762) | Diazyme Laboratories | 2016-11-21 |
| URight Hemoglobin A1c system, FORA A1c System (K142664) | Taidoc Technology Corporation | 2016-01-29 |
| SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set (K140827) | Sd Biosensor, Inc. | 2015-09-30 |
| Alere Afinion HbA1c, Alere Afinion AS100 Analyzer (K151809) | Alere Technologies AS | 2015-09-25 |
| HOME ACCESS AIC TEST (K141944) | Home Access Health Corp. | 2015-03-13 |
| A1c iGear System (K142789) | Sakae Corporation | 2014-12-16 |
| DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT (K133803) | Diazyme Laboratories | 2014-08-06 |
| HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM (K141750) | Infopia Co, Ltd. | 2014-07-24 |
| UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT (K140829) | Beckman Coulter, Inc. | 2014-07-14 |
| VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM (K140801) | Bio-Rad Laboratories, Inc. | 2014-06-25 |
| A1C GEAR SYSTEM (K130014) | Sakae Corporation | 2014-04-04 |
| MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS (K133344) | Sebia | 2014-03-28 |
| ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR (K131307) | Siemens Healthcare Diagnostics, Inc. | 2014-01-24 |
| VARIANT(TM) II TURBO HBA1C KIT - 2.0 (K130990) | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2013-05-09 |
| VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE (K130860) | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2013-04-25 |
| ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C (K121842) | Axis-Shield Diagnostics, Ltd. | 2012-12-12 |
| CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C (K122101) | Sebia | 2012-12-06 |
| VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM (K122472) | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2012-10-26 |
| GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY (K120199) | Beckman Coulter, Inc. | 2012-10-12 |
| LABONACHECK A1C (K111128) | Ceragem International, Inc. | 2012-09-13 |
| UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT (K121492) | Beckman Coulter, Inc. | 2012-09-11 |
| HEMOCUE HBA1C 501 (K121366) | Infopia Co, Ltd. | 2012-09-07 |
| ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT (K113437) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-06 |
| EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL (K120497) | Medica Corp. | 2012-05-14 |
| TINA-QUANT HBA1C GEN.2 (K110313) | Roche Diagnostics | 2011-12-23 |
| PREMIER HB9210 HBA1C ANALYZER (K112015) | Primus Corporation Dba Trinity Biotech | 2011-11-22 |
| ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY (K110934) | Siemens Healthcare Diagnostics | 2011-08-25 |
| AVIE A1C TEST SYSTEM (K093548) | Mec Dynamics Corp | 2011-07-20 |
| ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL (K100547) | Seppim S.A.S. | 2011-05-19 |
| DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT (K110188) | Diazyme Laboratories | 2011-05-17 |
| DIMENSIONS HB1C KIT, MODEL DF105A (K102510) | Siemens Healthcare Diagnostics | 2011-05-13 |
| AFINION ANALYZER (K110056) | Axis-Shield Poc AS | 2011-02-15 |
| DIMENSION VISA HBA1C, MODEL K3105A (K102045) | Siemens Heatlhcare Diagnostics, Inc. | 2011-02-14 |
| TQ HBA1C GEN3 (K102914) | Roche | 2011-01-20 |
| ST AIA PACK HBA1C (K100304) | Tosoh Bioscience, Inc. | 2010-08-27 |
| CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 (K082275) | Infopia Co, Ltd. | 2010-01-14 |
| S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 (K091711) | Alfa Wassermann Diagnostic Technologies, Inc. | 2009-12-11 |
| VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 (K090699) | Bio-Rad Laboratories, Inc. | 2009-07-27 |
| MODIFICATION TO AVIE A1C TEST SYSTEM (K091400) | Mec Dynamics Corp | 2009-06-11 |
| A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC (K090413) | Bayer Healthcare, LLC | 2009-05-14 |
| AVIE A1C TEST SYSTEM (K081269) | Mec Dynamics Corp | 2009-03-20 |
| ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS (K081895) | Siemens Medical Solutions Diagnostics | 2009-01-08 |
| ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT (K073309) | Horiba Abx | 2008-10-17 |
| G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 (K071132) | Tosoh Bioscience, Inc. | 2008-09-16 |
| DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID (K080618) | Jas Diagnostics, Inc. | 2008-05-23 |
| TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM (K072714) | Roche Diagnostics Corp. | 2008-04-18 |
| AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS (K072686) | Axis-Shield Diagnostics, Ltd. | 2008-03-17 |
| PRIMUS A1CARE ASSAY (K062658) | Primus Corp. | 2007-11-26 |
| DCA VANTAGE, MODEL 5075 (K071466) | Siemens Medical Solutions Diagnostics | 2007-10-09 |
| VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, (K070819) | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2007-06-25 |
| VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU (K070452) | Bio-Rad Laboratories, Inc. | 2007-05-07 |
| ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 (K063306) | Alfa Wassermann, Inc. | 2007-04-17 |
| MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON (K070734) | Diazyme Laboratories | 2007-04-09 |
| HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL (K063209) | Thermo Electron OY | 2007-03-21 |
| MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM (K063643) | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2006-12-27 |
| VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 (K063400) | Bio-Rad Laboratories, Inc. | 2006-12-01 |
| VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 (K060650) | Ortho-Clinical Diagnostics, Inc. | 2006-04-06 |
| DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS (K053411) | Microgenics Corp. | 2006-02-03 |
| D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM (K060001) | Bio-Rad Laboratories, Inc. | 2006-01-20 |
| TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST (K052464) | Roche Diagnostics Corp. | 2005-09-30 |
| HEMOGLOBIN A1C REAGENT SET (K051200) | Teco Diagnostics | 2005-08-08 |
| AFINION HBALC (K050574) | Axis-Shield Poc AS | 2005-07-22 |
| HBA1C ENZYMATIC ASSAY (K050178) | General Atomics | 2005-06-28 |
| INVIEW (K051321) | Metrika, Inc. | 2005-06-13 |
| SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT (K042459) | Beckman Coulter, Inc. | 2004-11-17 |
| DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT (K042193) | Diazyme Laboratories | 2004-10-29 |
| LIQUI-HEME GLYCO A1C ASSAY (K031296) | Biodiagnostic Intl | 2004-10-15 |
| THE VITROS 5,1 FS CHEMISTRY SYSTEM (K041764) | Ortho-Clinical Diagnostics | 2004-09-09 |
| G5 I HBA1C TEST, G5 II HBA1C TEST (K041635) | Provalis Diagnostics , Ltd. | 2004-08-16 |
| BIO-RAD D-10 DUAL PROGRAM (K041444) | Bio-Rad Laboratories, Inc. | 2004-06-09 |
| VARIANT II HEMOGLOBIN A1C (K040872) | Bio-Rad Laboratories, Inc. | 2004-04-15 |
| MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS (K033674) | Seradyn, Inc. | 2004-02-09 |
| A1CNOW FOR HOME AND PROFESSIONAL USE (K033847) | Metrika, Inc. | 2003-12-23 |
| OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) (K031380) | Olympus America, Inc. | 2003-11-14 |
| ATAC HEMOGLOBIN A1C REAGENT KIT (K031042) | Clinical Data, Inc. | 2003-11-03 |
| ARKIT HBA1C (K030553) | Arkray, Inc. | 2003-09-02 |
| D-10 HEMOGLOBIN A1C (K031043) | Bio-Rad Laboratories, Inc. | 2003-08-27 |
| HEMOGLOBIN A1C REAGENT SET (K031539) | Pointe Scientific, Inc., | 2003-08-06 |
| GLYCA-DIRECT FRUCTOSAMINE (K023654) | Polymedco, Inc. | 2003-05-02 |
| RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS (K023763) | Randox Laboratories, Ltd. | 2003-01-13 |
| A1CNOW FOR HOME USE (K022661) | Metrika, Inc. | 2002-12-13 |
| RANDOX HAEMOGLOBIN A1C (K021897) | Randox Laboratories, Ltd. | 2002-11-26 |
| HEMOGLOBIN A1C CONTROL (K021484) | Canterbury Scientific , Ltd. | 2002-06-14 |
| POLYMEDCO HBA1C TEST (K020532) | Polymedco, Inc. | 2002-04-24 |
| A1CNOW FOR PROFESSIONAL USE (K020235) | Metrika, Inc. | 2002-02-15 |