510(k) K211685 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Elecsys Testosterone II
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 6, 2022 |
| Received | Jun 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211685
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.