510(k) K032713 ยท LSR Reagent, Borrelia Serological Reagent
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
| Applicant | Boston Biomedica, Inc., West Bridgewater MA, US |
| Decision | Substantially Equivalent, Nov 24, 2003 |
| Received | Sep 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032713
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.