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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Panel
510(k) Number K180966
Device Name FilmArray Pneumonia Panel
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 Number866.3985
Classification Product Code
QDP  
Date Received04/13/2018
Decision Date 11/09/2018
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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