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

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.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code PCH
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

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