K-number	K083260
Device name	ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
Applicant	Roche Diagnostics
Product code	DDR
Device class	Class II
Decision date	Oct 16, 2009
Decision	Substantially Equivalent
Regulation	866.5680

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Source

View the full FDA submission: accessdata.fda.gov

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ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN

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