510(k) K163095 ยท LSR Reagent, Borrelia Serological Reagent
Lyme B. burgdorferi (IgG) MarStripe Test
| Applicant | Trinity Biotech, Buffalo NY, US |
| Decision | Substantially Equivalent, Feb 1, 2017 |
| Received | Nov 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163095
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.