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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Virus Panel Nucleic Acid Assay System
510(k) Number K152579
FOIA Releasable 510(k) K152579
Device Name FilmArray Respiratory Panel EZ (RP EZ)
Applicant
Biofire Diagnostics, LLC
390 Wakara Way
Salt Lake City,  UT  84108
Applicant Contact KRISTEN J. KANACK
Correspondent
Biofire Diagnostics, LLC
390 Wakara Way
Salt Lake City,  UT  84108
Correspondent Contact KRISTEN J. KANACK
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OEP   OOI   OOU   OQW  
OTG   OZX   OZY   OZZ  
Date Received09/10/2015
Decision Date 10/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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