510(k) K203296 ยท LSR Reagent, Borrelia Serological Reagent
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
| Applicant | Gold Standard Diagnostics, Davis CA, US |
| Decision | Substantially Equivalent, Mar 22, 2021 |
| Received | Nov 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203296
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.