510(k) K153607 ยท ONX Ovarian Adnexal Mass Assessment Score Test System
ROMA Calculation Tool Using Elecsys Assays
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 15, 2016 |
| Received | Dec 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153607
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.