510(k) K972095 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
IMMULITE 2000 PSA
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Aug 22, 1997 |
| Received | Jun 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972095
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.