510(k) K982948 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
ELECSYS PSA, MODEL # ELECSYS 1010
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 27, 1998 |
| Received | Aug 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982948
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.