510(k) K183446 ยท LSR Reagent, Borrelia Serological Reagent
BioPlex 2200 Lyme Total
| Applicant | Bio-Rad Laboratories, Benicia CA, US |
| Decision | Substantially Equivalent, Mar 12, 2019 |
| Received | Dec 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183446
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.