LCP — Assay, Glycosylated Hemoglobin Class II
FDA product code LCP covers "Assay, Glycosylated Hemoglobin", a Class II medical device regulated under 21 CFR 864.7470. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LCP
- Device Class
- Class II
- Regulation Number
- 864.7470
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| 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 |