Roche Diagnostics Operations, Inc.
FDA 510(k) & PMA Approved Devices — 2 products
Total Devices2
Categories2
Latest FDA decision2025-05-22
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P130015 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2025-05-22 | View |
| PMA | P140021 | Assay, enzyme linked immunosorbent, hepatitis c virus | MZO | 2019-04-24 | View |
No matching devices.