510(k) K893124 ยท GMT Antigens, Ha, Treponema Pallidum
OLYMPUS PK(TM) TP
| Applicant | Fujirebio Diagnostics,Inc., North Caldwell NJ, US |
| Decision | Substantially Equivalent, Nov 17, 1989 |
| Received | Apr 25, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893124
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.