510(k) K911640 ยท GMT Antigens, Ha, Treponema Pallidum
OLYMPUS PK TP(TM) SYSTEM, MODIFICATION
| Applicant | Olympus Corp., Lake Success NY, US |
| Decision | Substantially Equivalent, Jul 24, 1991 |
| Received | Apr 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911640
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.