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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitroprusside, Ketones (Urinary, Non-Quant.)
510(k) Number K192957
Device Name VivaChek Blood Glucose and B-Ketone Monitoring System
Applicant
Vivachek Biotech (Hangzhou) Co., Ltd.
1/2/3 F, Bldg. 1, 16 E. Zhenxing Rd., Yuhang
Hangzhou,  CN 311100
Applicant Contact Mark Qian
Correspondent
Vivachek Biotech (Hangzhou) Co., Ltd.
1/2/3 F, Bldg. 1, 16 E. Zhenxing Rd., Yuhang
Hangzhou,  CN 311100
Correspondent Contact Mark Qian
Regulation Number862.1435
Classification Product Code
JIN  
Date Received10/21/2019
Decision Date 06/05/2020
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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