Roche Diagnostics
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 450
- Inspections
- 23
- Compliance Actions
- 0
Known Names
roche diagnostics, roche diagnostics corporation, roche diagnostics operations
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252280 | Elecsys Anti-SARS-CoV-2 S | April 13, 2026 |
| K260046 | Elecsys Anti-HBc II | April 7, 2026 |
| K260049 | Elecsys Anti-HBc IgM | April 7, 2026 |
| K260048 | Elecsys Anti-HAV IgM | April 7, 2026 |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | April 2, 2026 |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | February 12, 2026 |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated | February 12, 2026 |
| K253839 | Elecsys Anti-SARS-CoV-2 | December 17, 2025 |
| K253188 | CoaguChek XS Plus System | October 24, 2025 |
| K252163 | Elecsys Phospho-Tau (181P) Plasma | October 8, 2025 |
| K242505 | Elecsys Cortisol III | July 17, 2025 |
| K250768 | Elecsys Anti-SARS-CoV-2 | June 10, 2025 |
| K241453 | Elecsys sFlt-1 and Elecsys PlGF | February 7, 2025 |
| K233060 | Elecsys Folate III | June 17, 2024 |
| K220272 | cobas pulse blood glucose monitoring system | April 26, 2024 |
| K231927 | Elecsys PTH , Elecsys PTH STAT | March 22, 2024 |
| K221890 | Elecsys Tg II | September 30, 2023 |
| K222610 | Elecsys Anti-Tg | September 15, 2023 |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STAT | July 21, 2023 |
| K231348 | Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF | June 5, 2023 |