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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Covid-19 Antigen Test
510(k) Number K241317
Device Name Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
No.8 Lizhishan Road, Science City, Huangpu District
Guangzhou,  CN 510663
Applicant Contact Xiao Kaiyu
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
No.8 Lizhishan Road, Science City, Huangpu District
Guangzhou,  CN 510663
Correspondent Contact Xiao Kaiyu
Classification Product Code
QYT  
Date Received05/10/2024
Decision Date 09/30/2024
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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