510(k) K033083 ยท LSR Reagent, Borrelia Serological Reagent
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
| Applicant | Trinity Biotech USA, Jamestown NY, US |
| Decision | Substantially Equivalent, Nov 26, 2003 |
| Received | Sep 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033083
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.