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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 K140407
Device Name FILMARRAY GASTROINTESTINAL (GI) PANEL
Applicant
Biofire Diagnostics
390 Wakara Way
Salt Lake City,  UT  84108
Applicant Contact BETH LINGENFELTER
Correspondent
Biofire Diagnostics
390 Wakara Way
Salt Lake City,  UT  84108
Correspondent Contact BETH LINGENFELTER
Regulation Number866.3990
Classification Product Code
PCH  
Date Received02/18/2014
Decision Date 05/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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