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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mers-cov and common respiratory pathogens semi-quantitative and quantitative multiplex nucleic acid detection system
510(k) Number K181324
Device Name FilmArray Pneumonia Panel plus
Applicant
BioFire Diagnostics, LLC
515 Colorow Drive
salt lake city,  UT  84108
Applicant Contact kristen j. kanack
Correspondent
BioFire Diagnostics, LLC
515 Colorow Drive
salt lake city,  UT  84108
Correspondent Contact kristen j. kanack
Regulation Number866.4001
Classification Product Code
QDS  
Date Received05/18/2018
Decision Date 11/15/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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