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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Groups, Streptococcus Spp.
510(k) Number K260342
Device Name AllTest Strep A Rapid Test
Applicant
Hangzhou AllTest Biotech Co., Ltd.
#550 Yinhai St.
Hangzhou,  CN 310018
Applicant Contact Rosa Wu
Correspondent
LSI International, Inc.
504 E Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Jenny Xia
Regulation Number866.3740
Classification Product Code
GTY  
Date Received02/02/2026
Decision Date 04/30/2026
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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