K-number	K061970
Device name	ELECSYS IGE II IMMUNOASSAY
Applicant	Roche Diagnostics
Product code	JHR
Device class	Class II
Decision date	Aug 31, 2006
Decision	Substantially Equivalent
Regulation	866.5510

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View the full FDA submission: accessdata.fda.gov

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ELECSYS IGE II IMMUNOASSAY

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