BIOFIRE FILMARRAY Gastrointestinal (GI) Panel— 510(k) K242367

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K242367 for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel, Substantially Equivalent on 2024-11-07. Applicant: Biofire Diagnostics, LLC.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code PCH
Advisory panel: Microbiology
Date received: 2024-08-09
Decision date: 2024-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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