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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 K263054
Device Name BIOFIRE Respiratory Panel 2.1 (RP2.1)
Applicant
Biofire Diagnostics
515 Colorow Dr.
Salt Lake City,  UT  84108
Applicant Contact Daisy Ramos
Correspondent
Biofire Diagnostics
515 Colorow Dr.
Salt Lake City,  UT  84108
Correspondent Contact Daisy Ramos
Regulation Number866.3981
Classification Product Code
QOF  
Date Received09/01/2026
Decision Date 09/22/2026
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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