510(k) K180264 ยท LSR Reagent, Borrelia Serological Reagent
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
| Applicant | Gold Standard Diagnostics, Davis CA, US |
| Decision | Substantially Equivalent, May 2, 2018 |
| Received | Jan 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180264
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.