K-number	K002948
Device name	K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
Applicant	Kamiya Biomedical Co.
Product code	DAP
Device class	Class II
Decision date	May 18, 2001
Decision	Substantially Equivalent
Regulation	864.7320

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K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT

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