Name: Predicase
Price: 199 USD

K-number	K002107
Device name	IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
Applicant	Scimedx Corp.
Product code	MVM
Device class	Class II
Decision date	Aug 4, 2000
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.

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