Name: Predicase
Price: 199 USD

K-number	K124021
Device name	ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM
Applicant	Arkray Factory, Inc.
Product code	CGA
Device class	Class II
Decision date	Jun 30, 2014
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM

Everything you need for a 510(k) submission. Nothing you don't.