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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 K211675
Device Name Dasky Disposable Sampling Tube (Model name: VSM02)
Applicant
Ningbo Dasky Life Science Co., Ltd.
# 6, Donggong 1st Rd., Yinzhou District
Ningbo,  CN 315000
Applicant Contact Wilson Wong
Correspondent
Ningbo Dasky Life Science Co., Ltd.
# 6, Donggong 1st Rd., Yinzhou District
Ningbo,  CN 315000
Correspondent Contact Wilson Wong
Classification Product Code
QBD  
Date Received06/01/2021
Decision Date 08/08/2022
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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