Roche Diagnostics
Roche Diagnostics appears in FDA public data with 0 recalls, 453 510(k) clearances, 24 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Aug 19, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 453
- Inspections
- 24
- Compliance Actions
- 0
Known Names
Roche Diagnostics, Roche Diagnostics Corporation, Roche Diagnostics Operations
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) Plasma | Aug 19, 2026 |
| K252323 | cobas pulse blood glucose monitoring system | Jun 12, 2026 |
| K252431 | Elecsys Calcitonin | Apr 24, 2026 |
| K252280 | Elecsys Anti-SARS-CoV-2 S | Apr 13, 2026 |
| K260048 | Elecsys Anti-HAV IgM | Apr 7, 2026 |
| K260049 | Elecsys Anti-HBc IgM | Apr 7, 2026 |
| K260046 | Elecsys Anti-HBc II | Apr 7, 2026 |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Apr 2, 2026 |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated | Feb 12, 2026 |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Feb 12, 2026 |
| K253839 | Elecsys Anti-SARS-CoV-2 | Dec 17, 2025 |
| K253188 | CoaguChek XS Plus System | Oct 24, 2025 |
| K252163 | Elecsys Phospho-Tau (181P) Plasma | Oct 8, 2025 |
| K242505 | Elecsys Cortisol III | Jul 17, 2025 |
| K250768 | Elecsys Anti-SARS-CoV-2 | Jun 10, 2025 |
| K241453 | Elecsys sFlt-1 and Elecsys PlGF | Feb 7, 2025 |
| K233060 | Elecsys Folate III | Jun 17, 2024 |
| K220272 | cobas pulse blood glucose monitoring system | Apr 26, 2024 |
| K231927 | Elecsys PTH , Elecsys PTH STAT | Mar 22, 2024 |
| K221890 | Elecsys Tg II | Sep 30, 2023 |