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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 K220059
Device Name Biosci™ Inactivated Transport Medium, Biosci™ ITM
Applicant
Shenzhen Dakewe Bio-engineering Co., Ltd.
No.14 Jinhui Road, Kengzi Street, Pingshan District
Shenzhen,  CN 518122
Applicant Contact Wei Jiang
Correspondent
Shenzhen Dakewe Bio-engineering Co., Ltd.
No.14 Jinhui Road, Kengzi Street, Pingshan District
Shenzhen,  CN 518122
Correspondent Contact Wei Jiang
Regulation Number866.2950
Classification Product Code
QBD  
Date Received01/10/2022
Decision Date 01/19/2023
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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