510(k) K161513 ยท LSR Reagent, Borrelia Serological Reagent
Anti-Borrelia burgdorferi US Westernblot (IgG)
| Applicant | Euroimmun US, Morris Plains NJ, US |
| Decision | Substantially Equivalent, Aug 25, 2016 |
| Received | Jun 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161513
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.