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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.
#14 Jinhui Rd., Kengzi St., Pingshan District
Shenzhen,  CN 518122
Applicant Contact Wei Jiang
Correspondent
Shenzhen Dakewe Bio-Engineering Co., Ltd.
#14 Jinhui Rd., Kengzi St., Pingshan District
Shenzhen,  CN 518122
Correspondent Contact Wei Jiang
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
Predetermined Change
Control Plan Authorized		 No
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