510(k) K010550 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Apr 24, 2001 |
| Received | Feb 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010550
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.