510(k) K021326 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
VIDAS TESTOSTERONE (TES), MODEL 30 418
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jul 18, 2002 |
| Received | Apr 26, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021326
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | bioMerieux, Inc. VIDAS Testosterone, Ref 30418 Terminated |
CDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.