K-number	K183306
Device name	GLUCOCARD® W onyx Blood Glucose Monitoring System
Applicant	Arkray Factory, Inc.
Product code	NBW
Device class	Class II
Decision date	Apr 10, 2019
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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GLUCOCARD® W onyx Blood Glucose Monitoring System

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