510(k) K151502 ยท ONX Ovarian Adnexal Mass Assessment Score Test System
ARCHITECT ROMA
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Apr 28, 2016 |
| Received | Jun 4, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151502
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.