VivaChek Blood Glucose And B-Ketone Monitoring System

Nitroprusside, Ketones (urinary, Non-quant.)

Vivachek Biotech (Hangzhou) Co., Ltd

The following data is part of a premarket notification filed by Vivachek Biotech (hangzhou) Co., Ltd with the FDA for Vivachek Blood Glucose And B-ketone Monitoring System.

Pre-market Notification Details

Device IDK192957
510k NumberK192957
Device Name:VivaChek Blood Glucose And B-Ketone Monitoring System
ClassificationNitroprusside, Ketones (urinary, Non-quant.)
Applicant Vivachek Biotech (Hangzhou) Co., Ltd 1/2/3 F, Building 1, 16 East Zhenxing Rd., Yuhang Hangzhou,  CN 311100
ContactMark Qian
CorrespondentMark Qian
Vivachek Biotech (Hangzhou) Co., Ltd 1/2/3 F, Building 1, 16 East Zhenxing Rd., Yuhang Hangzhou,  CN 311100
Product CodeJIN  
CFR Regulation Number862.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-21
Decision Date2020-06-05

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