510(k) K113846 ยท LSR Reagent, Borrelia Serological Reagent
BORRELIA BURGDORFERI IGM BLOT TEST
| Applicant | Gold Standard Diagnostics, Davis CA, US |
| Decision | Substantially Equivalent, Jun 1, 2012 |
| Received | Dec 29, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113846
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.