510(k) DEN150057 · PQO Anti-Müllerian Hormone Test System
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Unknown, Dec 19, 2016 |
| Received | Dec 9, 2015 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN150057
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.