510(k) K981839 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
ACS:CENTAUR PSA2 IMMUNOASSAY
| Applicant | Chiron Diagnostics Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Aug 12, 1998 |
| Received | May 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981839
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.