| K221326 | nova biomedical corporation | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | November 22, 2024 |
| K231465 | qurasense | Q-Pad Test System | December 6, 2023 |
| K214117 | abbott diagnostics technologies | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer | September 27, 2023 |
| K192987 | jana care | Aina HbA1c Monitoring System 2 | March 26, 2020 |
| K192369 | ixensor co | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | October 29, 2019 |
| K183230 | drawbridge health | OneDraw A1C Test System | August 15, 2019 |
| K181915 | ixensor co | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | April 12, 2019 |
| K180509 | ekf-diagnostic | Quo-Test A1c System | February 16, 2019 |
| K173127 | skyla corporation h.s.p.b | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c | September 25, 2018 |
| K170623 | alfa wassermann diagnostic technologies | ACE Hemoglobin A1c (HbA1c) Reagent | February 27, 2018 |
| K171650 | abbott rapid diagnostics | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | November 21, 2017 |
| K170147 | asahi kasei pharma corporation | Lucica Glycated Albumin-L | October 12, 2017 |
| K163633 | roche diagnostics operations | cobas HbA1c Test, cobas b 101 system | July 28, 2017 |
| K161533 | biohermes co | A1C EZ Glycohemoglobin Analysis System | June 16, 2017 |
| K162281 | sebia | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | February 17, 2017 |
| K160762 | diazyme laboratories | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Ass | November 21, 2016 |
| K142664 | taidoc technology corporation | URight Hemoglobin A1c system, FORA A1c System | January 29, 2016 |
| K140827 | sd biosensor | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set | September 30, 2015 |
| K151809 | alere technologies | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | September 25, 2015 |
| K141944 | home access health | HOME ACCESS AIC TEST | March 13, 2015 |