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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 K230035
Device Name BioSci™ Disposable Virus Sampling Tubes
Applicant
Shenzhen Dakewe Bio-engineering Co., Ltd.
Room 702-703, Building No.1,Shenzhen Biomedicine Innovations
Industrial Park, No.14 Jinhui Road, Kengzi Street, Pingshan
Shenzhen,  CN 518122
Applicant Contact Jiang Wei
Correspondent
Shenzhen Dakewe Bio-engineering Co., Ltd.
Room 702-703, Building No.1,Shenzhen Biomedicine Innovations
Industrial Park, No.14 Jinhui Road, Kengzi Street, Pingshan
Shenzhen,  CN 518122
Correspondent Contact Jiang Wei
Regulation Number866.2390
Classification Product Code
JSM  
Date Received01/05/2023
Decision Date 04/05/2023
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
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