510(k) K193051 ยท LSR Reagent, Borrelia Serological Reagent
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
| Applicant | DiaSorin, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Jan 29, 2020 |
| Received | Nov 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193051
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.