510(k) K963080 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Sep 27, 1996 |
| Received | Aug 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963080
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.