Name: Predicase
Price: 199 USD

K-number	K151759
Device name	Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
Applicant	The Binding Site Group , Ltd.
Product code	OPX
Device class	Class II
Decision date	Nov 6, 2015
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS

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