K-number	K103824
Device name	HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
Applicant	The Binding Site
Product code	CFN
Device class	Class II
Decision date	Feb 27, 2012
Decision	Substantially Equivalent
Regulation	866.5510

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Source

View the full FDA submission: accessdata.fda.gov

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HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS

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