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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
510(k) Number K251289
Device Name WELLlife COVID-19 Antigen Test Rx
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
#8 Lizhishan Rd., Science City, Huangpu District
Guangzhou,  CN 510663
Applicant Contact Kaiyu Xiao
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
#8 Lizhishan Rd., Science City, Huangpu District
Guangzhou,  CN 510663
Correspondent Contact Kaiyu Xiao
Classification Product Code
QVF  
Date Received04/25/2025
Decision Date 10/22/2025
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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