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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microbial Nucleic Acid Storage And Stabilization Device
510(k) Number K210440
Device Name Disposable Sampler Inactivated Transport Media, Nest ITM
Applicant
Wuxi Nest Biotechnology Co., Ltd.
No. 530 Xida Road, New District
Wuxi,  CN 214012
Applicant Contact Cheng Zhiwei
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road 1
Suite 300
Austin,  TX  78746
Correspondent Contact Giselle Zhang
Classification Product Code
QBD  
Date Received02/12/2021
Decision Date 09/20/2021
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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