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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 K243222
Device Name BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
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
Classification Product Code
QDS  
Subsequent Product Code
QDP  
Date Received10/07/2024
Decision Date 11/06/2024
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
Recalls CDRH Recalls
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