510(k) K965129 ยท LSR Reagent, Borrelia Serological Reagent
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
| Applicant | Wampole Laboratories, Cranbury NJ, US |
| Decision | Substantially Equivalent, Mar 26, 1997 |
| Received | Dec 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965129
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.