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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
510(k) Number K253318
Device Name Clungene RSV Antigen Rapid Test
Applicant
Hangzhou Clongene Biotech Co., Ltd.
#1 Yichuang Rd., Yuhang District
Hangzhou,  CN 311121
Applicant Contact Frank Zheng
Correspondent
LSI International, Inc.
504 E Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Jenny Xia
Regulation Number866.3480
Classification Product Code
GQG  
Date Received09/30/2025
Decision Date 01/30/2026
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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