K-number	K192957
Device name	VivaChek Blood Glucose and B-Ketone Monitoring System
Applicant	Vivachek Biotech (Hangzhou) Co., Ltd.
Product code	JIN
Device class	Class I
Decision date	Jun 5, 2020
Decision	Substantially Equivalent
Regulation	862.1435

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View the full FDA submission: accessdata.fda.gov

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VivaChek Blood Glucose and B-Ketone Monitoring System

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