Name: Predicase
Price: 199 USD

K-number	K101852
Device name	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
Applicant	Iris International Inc., A Division of Iris Iris I
Product code	KQO
Device class	Class I
Decision date	Mar 23, 2011
Decision	Substantially Equivalent
Regulation	862.2900

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Source

View the full FDA submission: accessdata.fda.gov

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CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT

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