K-number	K081827
Device name	HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
Applicant	The Binding Site, Ltd.
Product code	CFN
Device class	Class II
Decision date	Dec 19, 2008
Decision	Substantially Equivalent
Regulation	866.5510

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View the full FDA submission: accessdata.fda.gov

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HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS

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