510(k) K971502 ยท GMT Antigens, Ha, Treponema Pallidum
SERODIA TP-PA
| Applicant | Scimedx Tekfile Services, Denvill NJ, US |
| Decision | Substantially Equivalent, Nov 13, 1997 |
| Received | Apr 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971502
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.