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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 K211256
Device Name Disposable Sampler Viral Transport Media
Applicant
Wuxi Nest Biotechnology Co., Ltd.
#530 Xida Rd., New District
Wuxi,  CN 214112
Applicant Contact Cheng Zhiwei
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Randy Jiang
Regulation Number866.2390
Classification Product Code
JSM  
Date Received04/26/2021
Decision Date 05/20/2022
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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