510(k) K973101 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
PROSTATE SPECIFIC ANTIGEN METHOD
| Applicant | Dade Chemistry Systems, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Sep 18, 1997 |
| Received | Aug 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973101
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.