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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 K222601
Device Name FilmArray Pneumonia Panel plus
Applicant
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City,  UT  84108
Applicant Contact Kevin Bourzac
Correspondent
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City,  UT  84108
Correspondent Contact Kevin Bourzac
Classification Product Code
QDS  
Date Received08/29/2022
Decision Date 10/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
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
Recalls CDRH Recalls
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