510(k) K250925 ยท OVK Cytokeratin Fragments 21-1 Eia Kit
ADVIA Centaur Cytokeratin Fragment 21-1
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Dec 16, 2025 |
| Received | Mar 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250925
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.