Name: Predicase
Price: 199 USD

K-number	K062583
Device name	ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
Applicant	Phadia US, Inc.
Product code	MVM
Device class	Class II
Decision date	Dec 26, 2006
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01

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