510(k) K990234 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
QUALISYS PSA IMMUNOASSAY
| Applicant | Qualisys Diagnostics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 8, 1999 |
| Received | Jan 25, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990234
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.