510(k) K172722 ยท LSR Reagent, Borrelia Serological Reagent
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
| Applicant | Euroimmun Us, Inc., Mountain Lakes NJ, US |
| Decision | Substantially Equivalent, Dec 10, 2017 |
| Received | Sep 11, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172722
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.