K-number	K123785
Device name	DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
Applicant	Diazyme Laboratories
Product code	DDR
Device class	Class II
Decision date	Jun 7, 2013
Decision	Substantially Equivalent
Regulation	866.5680

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View the full FDA submission: accessdata.fda.gov

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DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET

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