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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents
510(k) Number K230719
Device Name BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
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
Regulation Number866.3981
Classification Product Code
QOF  
Subsequent Product Codes
OCC   OTG   OZE  
Date Received03/15/2023
Decision Date 04/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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