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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 K143005
Device Name FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0
Applicant
Biofire Diagnostics, LLC
390 Wakara Way
Salt Lake City,  UT  84108
Applicant Contact Kristen Kanack
Correspondent
Biofire Diagnostics, LLC
390 Wakara Way
Salt Lake City,  UT  84108
Correspondent Contact Kristen Kanack
Regulation Number866.3990
Classification Product Code
PCH  
Date Received10/20/2014
Decision Date 02/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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