K-number	K112120
Device name	DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
Applicant	Diazyme Laboratories
Product code	GHH
Device class	Class II
Decision date	Jan 24, 2013
Decision	Substantially Equivalent
Regulation	864.7320

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View the full FDA submission: accessdata.fda.gov

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DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET

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