510(k) K252431 ยท JKR Radioimmunoassay, Calcitonin
Elecsys Calcitonin
| Applicant | Roche Diagnostics GmbH, Mannheim, DE |
| Decision | Substantially Equivalent, Apr 24, 2026 |
| Received | Aug 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252431
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.