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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device to detect and identify selected microbial agents that cause acute febrile illness
510(k) Number K220870
Device Name BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
Applicant
BioFire Defense, LLC
79 W 4500 S, Suite 14
Salt Lake City,  UT  84107
Applicant Contact Cynthia Pillips
Correspondent
BioFire Defense, LLC
79 W 4500 S, Suite 14
Salt Lake City,  UT  84107
Correspondent Contact David Rabiger
Regulation Number866.3966
Classification Product Code
QMV  
Subsequent Product Code
PMN  
Date Received03/25/2022
Decision Date 10/20/2022
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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