K-number	K182593
Device name	KET-1 Blood Ketone Monitoring System
Applicant	Apex BioTechnology Corp.
Product code	JIN
Device class	Class I
Decision date	Dec 18, 2018
Decision	Substantially Equivalent
Regulation	862.1435

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Source

View the full FDA submission: accessdata.fda.gov

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KET-1 Blood Ketone Monitoring System

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