510(k) K163695 ยท LSR Reagent, Borrelia Serological Reagent
Borrelia B31 ViraChip IgM Test Kit
| Applicant | Viramed Biotech AG, Planegg, DE |
| Decision | Substantially Equivalent, Aug 22, 2017 |
| Received | Dec 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163695
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.