510(k) K980716 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
| Applicant | Nichols Institute Diagnostics, San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Apr 3, 1998 |
| Received | Jan 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980716
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.