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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K262172
Device Name BIOFIRE FILMARRAY Gastrointestinal 1.1 (GI1.1) Panel; BIOFIRE FILMARRAY Gastrointestinal 1.1 (GI1.1) Panel Mid
Applicant
Biofire Diagnostics, LLC
515 Colorow Dr.
Salt Lake City,  UT  84108
Applicant Contact Rebekah Stewart
Correspondent
Biofire Diagnostics, LLC
515 Colorow Dr.
Salt Lake City,  UT  84108
Correspondent Contact Rebekah Stewart
Regulation Number866.3990
Classification Product Code
PCH  
Date Received06/26/2026
Decision Date 11/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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