510(k) K964351 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
ELECSYS PSA ASSAY
| Applicant | Boehringer Mannheim Corp., Concord CA, US |
| Decision | Substantially Equivalent, Jul 25, 1997 |
| Received | Nov 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964351
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.