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

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

Clearance details

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

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