K-number	K130628
Device name	PATHFAST CK-MB-II CALIBRATORS
Applicant	Mitsubishi Chemical Medience Corporation
Product code	JIT
Device class	Class II
Decision date	Oct 4, 2013
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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PATHFAST CK-MB-II CALIBRATORS

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