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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 K230917
Device Name FebriDx Bacterial / Non-bacterial Point of Care Assay
Applicant
Lumos Diagnostics, Inc.
2724 Loker Avenue
Carlsbad,  CA  92010
Applicant Contact Sue Hibbeln
Correspondent
Lumos Diagnostics, Inc.
2724 Loker Avenue
Carlsbad,  CA  92010
Correspondent Contact Sue Hibbeln
Regulation Number866.3230
Classification Product Code
QXA  
Date Received04/03/2023
Decision Date 06/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02018198
Reviewed by Third Party No
Combination Product No
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