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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 K212727
Device Name FilmArray Pneumonia Panel
Applicant
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City,  UT  84108
Applicant Contact Kevin Bourzac
Correspondent
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City,  UT  84108
Correspondent Contact Kevin Bourzac
Regulation Number866.3985
Classification Product Code
QDP  
Date Received08/27/2021
Decision Date 09/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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