Abbott Laboratories Diagnostics Division
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240468 | Alkaline Phosphatase | October 16, 2024 |
| K230994 | Alinity i STAT High Sensitivity Troponin-I | May 4, 2023 |
| K202525 | Alinity i STAT High Sensitivity Troponin-I | May 19, 2022 |
| K191595 | ARCHITECT STAT High Sensitivity Troponin-I | September 13, 2019 |