K-number	K921763
Device name	TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
Applicant	Hybritech, Inc.
Product code	JHY
Device class	Class II
Decision date	Jun 9, 1992
Decision	Substantially Equivalent
Regulation	862.1215

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TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY

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