510(k) K142038 ยท LSR Reagent, Borrelia Serological Reagent
EUROIMMUN LYME ELISA(IgG/IgM)
| Applicant | Euroimmun US, Morris Plains NJ, US |
| Decision | Substantially Equivalent, May 4, 2015 |
| Received | Jul 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142038
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.