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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 K241194
Device Name BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
Applicant
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City,  UT  84108
Applicant Contact Karli Plenert
Correspondent
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City,  UT  84108
Correspondent Contact Karli Plenert
Regulation Number866.3981
Classification Product Code
QOF  
Subsequent Product Codes
NSU   OCC   OZE   PGX  
Date Received04/30/2024
Decision Date 05/30/2024
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
Predetermined Change
Control Plan Authorized		 No
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