K-number	K230404
Device name	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Applicant	Biofire Diagnostics, LLC
Product code	PCH
Device class	Class II
Decision date	Mar 16, 2023
Decision	Substantially Equivalent
Regulation	866.3990

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Source

View the full FDA submission: accessdata.fda.gov

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BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

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