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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 K170604
Device Name FilmArray Respiratory Panel 2 (RP2)
Applicant
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City,  UT  84108
Applicant Contact Kristen J. Kanack
Correspondent
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City,  UT  84108
Correspondent Contact Kristen J. Kanack
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OEP   OOU   OTG   OZX  
OZY   OZZ  
Date Received03/01/2017
Decision Date 05/30/2017
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
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