LCP
- Product code
- LCP
- Device name
- Assay, Glycosylated Hemoglobin
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.7470
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 249 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K221326 | 2024-11-22 | Nova Biomedical Corporation | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | |
| K231465 | 2023-12-06 | Qurasense | Q-Pad Test System | |
| K214117 | 2023-09-27 | Abbott Diagnostics Technologies AS | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 … | FDA |
Official FDA classification page: LCP
Classification and pathway per current FDA publications. Data from openFDA (CC0).