510(k) K081362 ยท LSR Reagent, Borrelia Serological Reagent
PLATELIA LYME IGM
| Applicant | Bio-Rad, Beverly MA, US |
| Decision | Substantially Equivalent, Jun 26, 2008 |
| Received | May 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081362
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.