| Medconn 8K Glycated Hemoglobin Test System (K252749) | Shanghai Medconn Medical Technology Co., Ltd. | 2026-01-06 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (K250073) | Tosoh Bioscience, Inc. | 2025-10-03 |
| Medconn Glycated Hemoglobin Test system (K242911) | Shanghai Medconn Medical Technology Co., Ltd. | 2025-06-20 |
| Hipro Glycosylated Hemoglobin (HbA1c) Test System (K220999) | Shijiazhuang Hipro Biotechnology Co., Ltd. | 2024-09-12 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (K200904) | Tosoh Bioscience, Inc. | 2021-08-05 |
| ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (K200256) | Siemens Healthcare Diagnostics, Inc. | 2021-07-02 |
| Tina-quant Hemoglobin A1cDx Gen.3 (K193053) | Roche Diagnostics Operations (Rdo) | 2020-03-26 |
| HbA1c Advanced (K182651) | Beckman Coulter Ireland, Inc. | 2019-01-16 |
| Afinion HbA1c Dx on Afinion 2 (K182988) | Alere Technologies AS | 2018-11-29 |
| Dimension Hemoglobin A1c Assay (K173909) | Siemens Healthcare Diagnostics, Inc. | 2018-07-13 |
| SEKURE HbA1c Assay (K173206) | Sekisui Diagnostics P.E.I., Inc. | 2018-07-12 |
| Afinion HbA1c Dx (K180296) | Alere Technologies AS | 2018-05-07 |
| CAPILLARYS Hb A1c (K171861) | Sebia | 2018-02-07 |
| ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay (K171771) | Siemens Healthcare Diagnostics, Inc. | 2017-12-04 |
| CAPI 3 Hb A1c (K171537) | Sebia | 2017-09-12 |
| ADAMS A1c HA-8180V, CALIBRATOR 80 (K162822) | Arkray Factory, Inc. | 2017-06-29 |
| cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay (K160571) | Roche Diagnostics Operations (Rdo) | 2016-12-19 |
| D-10 Hemoglobin A1c Program (K161687) | Bio-Rad Laboratories, Inc. | 2016-10-14 |
| D-100 HbA1c, D-100 HbA1c Calibrator Pack (K151321) | Bio-Rad Laboratories, Inc. | 2015-12-09 |
| VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II (K142595) | Ortho Clinical Diagnostics | 2015-06-04 |
| Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls (K140654) | Abbott Laboratories | 2015-05-22 |
| VARIANT II TURBO HbA1c Kit - 2.0 (K142448) | Bio-Rad Laboratories, Inc. | 2015-03-24 |
| HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS (K130255) | Abbott Laboratories | 2014-02-28 |
| AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 (K131580) | Tosoh Bioscience, Inc. | 2014-01-23 |
| COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY (K121610) | Roche Diagnostics Operations | 2013-08-08 |
| TINA-QUANT HBA1C GEN. 2 TEST SYSTEM (DEN130002) | Roche Diagnostics | 2013-05-23 |