Sofia Lyme FIA; Sofia 2 Campylobacter FIA— 510(k) K254295

Name: FDA 510(k) clearance K254295
Creator: U.S. Food and Drug Administration
Published: 2026-07-10

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

FDA 510(k) clearance K254295 for Sofia Lyme FIA; Sofia 2 Campylobacter FIA, Substantially Equivalent on 2026-07-10. Applicant: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). Device class: 2.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2025-12-31
Decision date: 2026-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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