510(k) K980376 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Apr 23, 1998 |
| Received | Jan 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980376
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.