Axis-Shield Diagnostics Limited
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K183088 | ADVIA Centaur Erythropoietin (EPO) assay | August 2, 2019 |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assay | December 21, 2018 |
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Mas | August 4, 2016 |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Co | July 26, 2016 |