510(k) K150588 ยท ONX Ovarian Adnexal Mass Assessment Score Test System
OVA1 Next Generation
| Applicant | Vermillion, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Mar 18, 2016 |
| Received | Mar 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150588
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.