K-number	K140686
Device name	HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
Applicant	The Binding Site Group , Ltd.
Product code	PDE
Device class	Class II
Decision date	Aug 6, 2014
Decision	Substantially Equivalent
Regulation	866.5510

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View the full FDA submission: accessdata.fda.gov

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HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS

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