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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrumentation For Clinical Multiplex Test Systems
510(k) Number K143178
Device Name FilmArray 2.0 System
Applicant
Biofire Diagnostics, LLC
390 Wakara Way
Salt Lake City,  UT  84108
Applicant Contact Kristen Kanack, PhD
Correspondent
Biofire Diagnostics, LLC
390 Wakara Way
Salt Lake City,  UT  84108
Correspondent Contact Kristen Kanack, PhD
Regulation Number862.2570
Classification Product Code
NSU  
Date Received11/04/2014
Decision Date 01/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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