510(k) K093421 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
ELECSYS TESTOSTERONE II IMMUNOASSAY
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 23, 2010 |
| Received | Nov 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093421
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.