Name: Predicase
Price: 199 USD

K-number	K032819
Device name	GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM
Applicant	Bionostics, Inc.
Product code	JJX
Device class	Class I
Decision date	Oct 20, 2003
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM

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