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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 K213954
Device Name BIOFIRE SPOTFIRE Respiratory (R) Panel
Applicant
BioFire Diagnostics
515 Colorow Drive
Salt Lake City,  UT  84108
Applicant Contact Kevin Bourzac
Correspondent
BioFire Diagnostics
515 Colorow Drive
Salt Lake City,  UT  84108
Correspondent Contact Kevin Bourzac
Regulation Number866.3981
Classification Product Code
QOF  
Subsequent Product Codes
NSU   OCC   OEM   OOU   OTG  
OZE   OZX   OZY   OZZ  
Date Received12/17/2021
Decision Date 02/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
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