K-number	K012422
Device name	K-ASSAY D-DIMER CONTROLS
Applicant	Kamiya Biomedical Co.
Product code	GGC
Device class	Class II
Decision date	Aug 21, 2001
Decision	Substantially Equivalent
Regulation	864.5425

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View the full FDA submission: accessdata.fda.gov

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K-ASSAY D-DIMER CONTROLS

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