510(k) K100831 ยท OVK Cytokeratin Fragments 21-1 Eia Kit
CYFRA 21-1 EIA MODEL 211-10
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, May 26, 2011 |
| Received | Mar 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100831
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.