K-number	K850159
Device name	TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT
Applicant	Hybritech, Inc.
Product code	JHI
Device class	Class II
Decision date	Mar 4, 1985
Decision	Substantially Equivalent
Regulation	862.1155

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TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT

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