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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 K143171
Device Name FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
Applicant
Biofire Diagnostics, LLC.
390 Wakara Way
salt lake city,  UT  84108
Applicant Contact kristen kanack, phd
Correspondent
Biofire Diagnostics, LLC.
390 Wakara Way
salt lake city,  UT  84108
Correspondent Contact kristen kanack, phd
Regulation Number866.3365
Classification Product Code
PEN  
Subsequent Product Codes
OOI   PAM  
Date Received11/04/2014
Decision Date 01/30/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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