Name: Predicase
Price: 199 USD

K-number	K051915
Device name	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER
Applicant	The Binding Site, Ltd.
Product code	DFH
Device class	Class II
Decision date	Sep 6, 2005
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 KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER

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