K-number	K081403
Device name	GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
Applicant	Bionostics, Inc.
Product code	JJX
Device class	Class I
Decision date	Jul 25, 2008
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK

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