K254295
- 510(k) number
- K254295
- Device name
- Sofia Lyme FIA; Sofia 2 Campylobacter FIA
- Applicant
- Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) CA · US
- Product code
- LSR — Reagent, Borrelia Serological Reagent
- Decision date
- 2026-07-10
- Date received
- 2025-12-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K254295.pdf
Official FDA record: K254295
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.