510(k) K202573 ยท LSR Reagent, Borrelia Serological Reagent
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
| Applicant | DiaSorin, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Feb 18, 2021 |
| Received | Sep 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202573
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.