510(k) K915164 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
SRI TESTOSTERONE ENZYME IMMUNOASSAY
| Applicant | Serono-Baker Diagnostics, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Mar 2, 1992 |
| Received | Nov 14, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915164
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.