K-number	K922047
Device name	IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064
Applicant	Medix Biotech, Inc.
Product code	DGC
Device class	Class II
Decision date	Aug 5, 1992
Decision	Substantially Equivalent
Regulation	866.5510

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IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064

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