K-number	K870520
Device name	TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
Applicant	Hybritech, Inc.
Product code	CGJ
Device class	Class I
Decision date	Mar 10, 1987
Decision	Substantially Equivalent
Regulation	862.1300

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TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY

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