510(k) K853865 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO
| Applicant | Pantex, Div. Bio-Analysis, Inc., Santa Monica CA, US |
| Decision | Substantially Equivalent, Oct 15, 1985 |
| Received | Sep 17, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853865
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.