K-number	K894761
Device name	TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT
Applicant	Hybritech, Inc.
Product code	CGJ
Device class	Class I
Decision date	Sep 13, 1989
Decision	Substantially Equivalent
Regulation	862.1300

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TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT

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