510(k) K905038 ยท GMT Antigens, Ha, Treponema Pallidum
OLYMPUS PK-TP ABSORBENT KIT
| Applicant | Fujirebio America, Inc., Fairfield NJ, US |
| Decision | Substantially Equivalent, May 6, 1991 |
| Received | Nov 6, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905038
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.