510(k) K972021 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Oct 31, 1997 |
| Received | Jun 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972021
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.