510(k) K980351 ยท LSR Reagent, Borrelia Serological Reagent
BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
| Applicant | Boston Biomedica, Inc., West Bridgewater MA, US |
| Decision | Substantially Equivalent, Mar 5, 1999 |
| Received | Jan 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980351
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.