Name: Predicase
Price: 199 USD

K-number	K160819
Device name	Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
Applicant	The Binding Site Group , Ltd.
Product code	OPX
Device class	Class II
Decision date	Jun 16, 2016
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit

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