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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
510(k) Number K261475
Device Name BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
Applicant
Biofire Defense, LLC
79 W 4500 S
Suite 14
Salt Lake City,  UT  84107
Applicant Contact David Rabiger
Correspondent
Biofire Defense, LLC
79 W 4500 S
Suite 14
Salt Lake City,  UT  84107
Correspondent Contact David Rabiger
Regulation Number866.3920
Classification Product Code
PMN  
Date Received05/05/2026
Decision Date 07/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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