K-number	K941057
Device name	SPECIFIC IGE EIA-ULTRA ASSAY
Applicant	Hycor Biomedical, Inc.
Product code	DHB
Device class	Class II
Decision date	Jan 20, 1995
Decision	Substantially Equivalent
Regulation	866.5750

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View the full FDA submission: accessdata.fda.gov

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SPECIFIC IGE EIA-ULTRA ASSAY

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