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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 K243463
Device Name BIOFIRE FILMARRAY Tropical Fever Panel
Applicant
BioFire Diagnostics, LLC (bioMerieux)
515 Colorow Drive
Salt Lake City,  UT  84108
Applicant Contact Karli Plenert
Correspondent
BioFire Diagnostics, LLC (bioMerieux)
515 Colorow Drive
Salt Lake City,  UT  84108
Correspondent Contact Karli Plenert
Regulation Number866.3966
Classification Product Code
QMV  
Date Received11/08/2024
Decision Date 12/05/2024
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
Predetermined Change
Control Plan Authorized		 No
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