510(k) K122986 ยท LSR Reagent, Borrelia Serological Reagent
VIDAS LYME IGG
| Applicant | Biomerieux S.A., Marcy L Etoile, FR |
| Decision | Substantially Equivalent, Mar 5, 2013 |
| Received | Sep 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122986
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.