510(k) K951685 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
AURAFLEX TESTOSTERONE CALIBRATOR PACK
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Nov 14, 1995 |
| Received | Apr 10, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951685
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.