K-number	K972666
Device name	TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
Applicant	Hybritech, Inc.
Product code	CIN
Device class	Class II
Decision date	Sep 11, 1997
Decision	Substantially Equivalent
Regulation	862.1050

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TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY

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