Name: Predicase
Price: 199 USD

K-number	K031016
Device name	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
Applicant	The Binding Site, Ltd.
Product code	DEH
Device class	Class II
Decision date	Jul 15, 2003
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 DAD BEHRING NEPHELOMETER II

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