Abbott Diagnostics Technologies AS
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2736-2024 | Class II | Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. | June 17, 2024 |
| Z-2192-2020 | Class II | Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1 | March 23, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer | September 27, 2023 |