Name: Predicase
Price: 199 USD

K-number	K070900
Device name	FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
Applicant	The Binding Site, Ltd.
Product code	DFH
Device class	Class II
Decision date	Nov 30, 2007
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 KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT

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