510(k) K965085 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
ENZYMUN-TEST PSA
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 19, 1997 |
| Received | Dec 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965085
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.