K-number	K952745
Device name	CREATINE KINASE REAGENT SYSTEM
Applicant	Medical Diagnostic Technologies, Inc.
Product code	CGS
Device class	Class II
Decision date	Aug 11, 1995
Decision	Substantially Equivalent
Regulation	862.1215

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View the full FDA submission: accessdata.fda.gov

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CREATINE KINASE REAGENT SYSTEM

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