510(k) K254295 ยท LSR Reagent, Borrelia Serological Reagent
Sofia Lyme FIA; Sofia 2 Campylobacter FIA
| Applicant | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho), San Diego CA, US |
| Decision | Substantially Equivalent, Jul 10, 2026 |
| Received | Dec 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254295
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.