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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gram-Negative Bacteria And Associated Resistance Markers
510(k) Number K193519
Device Name BioFire Blood Culture Identification 2 (BCID2) Panel
Applicant
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City,  UT  84108
Applicant Contact Kristen Kanack
Correspondent
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City,  UT  84108
Correspondent Contact Kristen Kanack
Regulation Number866.3365
Classification Product Code
PEN  
Subsequent Product Codes
PAM   PEO  
Date Received12/19/2019
Decision Date 03/18/2020
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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