K-number	K854708
Device name	DART CK-MB REAGENT SYSTEM
Applicant	Coulter Electronics, Inc.
Product code	JHS
Device class	Class II
Decision date	Dec 30, 1985
Decision	Substantially Equivalent
Regulation	862.1215

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View the full FDA submission: accessdata.fda.gov

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DART CK-MB REAGENT SYSTEM

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