510(k) K103358 ยท ONX Ovarian Adnexal Mass Assessment Score Test System
ROMA (HE4 EIA + ARCHITECT CA 125 II)
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Unknown, Sep 1, 2011 |
| Received | Nov 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103358
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.