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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 K232954
Device Name BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
BioFire Diagnostics, LLC
515 Colorow Drive
Salt Lake City,  UT  84108
Applicant Contact Kevin Bourzac
BioMerieux, Inc
515 Colorow Drive
Salt Lake City,  UT  84108
Correspondent Contact Kevin Bourzac
Regulation Number866.3981
Classification Product Code
Date Received09/21/2023
Decision Date 03/26/2024
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