K-number	K872063
Device name	TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II
Applicant	Hybritech, Inc.
Product code	JHY
Device class	Class II
Decision date	Jun 19, 1987
Decision	Substantially Equivalent
Regulation	862.1215

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TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II

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