510(k) K163713 ยท LSR Reagent, Borrelia Serological Reagent
Sofia Lyme FIA, Sofia Lyme Control Set
| Applicant | Quidel Corporation, San Diego, CA, US |
| Decision | Substantially Equivalent, Oct 20, 2017 |
| Received | Dec 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163713
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.