510(k) K173496 ยท LSR Reagent, Borrelia Serological Reagent
Sofia 2 Lyme FIA, Sofia Lyme Control Set
| Applicant | Quidel Corporation, San Diego, CA, US |
| Decision | Substantially Equivalent, Aug 30, 2018 |
| Received | Nov 13, 2017 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K173496
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.