K-number	K062972
Device name	PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
Applicant	Roche Diagnostics Corp.
Product code	JJX
Device class	Class I
Decision date	Oct 13, 2006
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS

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