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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Propagating Transport
510(k) Number K211707
Device Name BioTeke Sterile Disposable Virus Sampling Kit
Applicant
Bioteke Corporation (Wuxi) Co., Ltd.
4th Floor, D5, # 1719, Huishan Ave.
Wuxi City,  CN 21474
Applicant Contact Zhitu Zhou
Correspondent
QSR Consulting
10807 Dakota Ranch Rd.
Santee,  CA  92071
Correspondent Contact Kenneth Kleinhenz
Regulation Number866.2390
Classification Product Code
JSM  
Date Received06/03/2021
Decision Date 05/04/2022
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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