510(k) K973243 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
ACTIVE PSA ELISA (DSL-10-9700)
| Applicant | Diagnostic Systems Laboratories, Inc., Webster TX, US |
| Decision | Substantially Equivalent, Aug 3, 1998 |
| Received | Aug 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973243
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.