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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K233058
Device Name VivaChek Link Plus Blood Glucose Monitoring System
Applicant
Vivachek Biotech (Hangzhou) Co., Ltd.
Level 2, Block 2, 146 E. Chaofeng Rd.
Yuhang Economy Development Zone
Hangzhou,  CN 311100
Applicant Contact Mark Qian
Correspondent
Vivachek Biotech (Hangzhou) Co., Ltd.
Level 2, Block 2, 146 E. Chaofeng Rd.
Yuhang Economy Development Zone
Hangzhou,  CN 311100
Correspondent Contact Mark Qian
Regulation Number862.1345
Classification Product Code
NBW  
Date Received09/25/2023
Decision Date 12/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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