K-number	K022654
Device name	MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
Applicant	Roche Diagnostics Corp.
Product code	JHY
Device class	Class II
Decision date	Aug 29, 2002
Decision	Substantially Equivalent
Regulation	862.1215

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MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

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