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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
510(k) Number K260787
Device Name FebriDx Bacterial/Non-bacterial Assay
Applicant
Lumos Diagnostics, Inc.
2724 Loker Ave. W.
Carlsbad,  CA  92010
Applicant Contact Susan Hibbeln
Correspondent
Lumos Diagnostics, Inc.
2724 Loker Ave. W.
Carlsbad,  CA  92010
Correspondent Contact Susan Hibbeln
Classification Product Code
QXA  
Date Received03/10/2026
Decision Date 03/24/2026
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
Predetermined Change
Control Plan Authorized		 No
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