K-number	K113670
Device name	ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
Applicant	Infopia Co, Ltd.
Product code	CGA
Device class	Class II
Decision date	May 8, 2012
Decision	Substantially Equivalent
Regulation	862.1345

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View the full FDA submission: accessdata.fda.gov

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ELEMENT BLOOD GLUCOSE MONITORING SYSTEM

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