510(k) K072939 ยท OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4)
HE4 EIA, MODEL: 404-10 US
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jun 9, 2008 |
| Received | Oct 17, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072939
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.