510(k) K160915 ยท OVK Cytokeratin Fragments 21-1 Eia Kit
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 14, 2016 |
| Received | Apr 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160915
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.