Roche Professional Diagnostics
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K143534 | Elecsys CA-125 II assay | August 6, 2015 |
| K100903 | ANTI-HAV | October 5, 2010 |