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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 K133343
Device Name WONDFO RAPID STREP A TEST
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
504 E. Diamond Ave. Suite F
Gaithersburg,  MD  20878
Applicant Contact Joe Shia
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
504 E. Diamond Ave. Suite F
Gaithersburg,  MD  20878
Correspondent Contact Joe Shia
Regulation Number866.3740
Classification Product Code
GTY  
Date Received10/30/2013
Decision Date 01/31/2014
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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