510(k) K203757 · PQO Anti-Müllerian Hormone Test System
Elecsys AMH
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 10, 2022 |
| Received | Dec 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203757
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.