510(k) K964595 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
OPUS PSA TEST SYSTEM
| Applicant | Behring Diagnostics, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Jun 24, 1997 |
| Received | Nov 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964595
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.