510(k) K001935 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Aug 22, 2000 |
| Received | Jun 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001935
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.