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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Respiratory Virus Antigen Detection Test
510(k) Number K251563
Device Name WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test
Applicant
Wondfo USA Co, Ltd.
6720 Cobra Way
San Diego,  CA  92121
Applicant Contact Kaiyu Xiao
Correspondent
Wondfo USA Co, Ltd.
6720 Cobra Way
San Diego,  CA  92121
Correspondent Contact Kaiyu Xiao
Classification Product Code
SCA  
Date Received05/22/2025
Decision Date 08/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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