BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid— 510(k) K243885

Name: FDA 510(k) clearance K243885
Creator: U.S. Food and Drug Administration
Published: 2025-01-16

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K243885 for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid, Substantially Equivalent on 2025-01-16. Applicant: Biofire Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2024-12-18
Decision date: 2025-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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