K-number	K003158
Device name	ROCHE DIAGNOSTICS CK-MB
Applicant	Roche Diagnostics Corp.
Product code	JHW
Device class	Class II
Decision date	Dec 18, 2000
Decision	Substantially Equivalent
Regulation	862.1215

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View the full FDA submission: accessdata.fda.gov

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ROCHE DIAGNOSTICS CK-MB

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