510(k) K103676 ยท OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4)
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jul 19, 2011 |
| Received | Dec 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103676
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.