Name: Predicase
Price: 199 USD

K-number	K161854
Device name	Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
Applicant	The Binding Site Group , Ltd.
Product code	PCN
Device class	Class II
Decision date	Oct 4, 2016
Decision	Substantially Equivalent
Regulation	866.5510

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Source

View the full FDA submission: accessdata.fda.gov

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Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS

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