K-number	K072288
Device name	PATHFAST D-DIMER
Applicant	Mitsubishi Kagaku Iatron
Product code	GHH
Device class	Class II
Decision date	May 6, 2009
Decision	Substantially Equivalent
Regulation	864.7320

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View the full FDA submission: accessdata.fda.gov

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PATHFAST D-DIMER

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