510(k) K994221 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
BAYER PSA ASSAY
| Applicant | Bayer Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Apr 13, 2000 |
| Received | Dec 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994221
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.