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U.S. Department of Health and Human Services

Devices@FDA
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Help | Download Files | More about CDRH 510(K)

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Device Classification Name Respiratory Panel
510(k) Number K180966
Device Name FilmArray Pneumonia Panel
Applicant
Biofire Diagnostics, LLC
515 Colorow Dr.
Salt Lake City,  UT  84108
Applicant Contact Kristen J. Kanack
Correspondent
Biofire Diagnostics, LLC
515 Colorow Dr.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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