510(k) K974809 ยท LSR Reagent, Borrelia Serological Reagent
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
| Applicant | Boston Biomedica, Inc., West Bridgewater MA, US |
| Decision | Substantially Equivalent, Feb 5, 1998 |
| Received | Dec 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974809
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.