K-number	K140396
Device name	FREELITE HUMAN LAMBDA FREE KIT
Applicant	The Binding Site Group , Ltd.
Product code	DEH
Device class	Class II
Decision date	Apr 16, 2014
Decision	Substantially Equivalent
Regulation	866.5550

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Source

View the full FDA submission: accessdata.fda.gov

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FREELITE HUMAN LAMBDA FREE KIT

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