BioFire Warrior Panel; BioFire Warrior Panel Control Kit— 510(k) K243822

Name: FDA 510(k) clearance K243822
Creator: U.S. Food and Drug Administration
Published: 2025-03-12

Substantially Equivalent

Biofire Defense, LLC

FDA 510(k) clearance K243822 for BioFire Warrior Panel; BioFire Warrior Panel Control Kit, Substantially Equivalent on 2025-03-12. Applicant: Biofire Defense, LLC.

Clearance details

Applicant: Biofire Defense, LLC
Product code: Code PRD
Advisory panel: Immunology
Date received: 2024-12-12
Decision date: 2025-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.