510(k) K901054 ยท LSR Reagent, Borrelia Serological Reagent
BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE
| Applicant | Bion Ent., Ltd., Park Ridge IL, US |
| Decision | Substantially Equivalent, Apr 5, 1990 |
| Received | Mar 6, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901054
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.