K-number	K862370
Device name	DART AMYLASE-D.S. REAGENT SYSTEM
Applicant	Coulter Electronics, Inc.
Product code	CIJ
Device class	Class II
Decision date	Aug 1, 1986
Decision	Substantially Equivalent
Regulation	862.1070

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View the full FDA submission: accessdata.fda.gov

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DART AMYLASE-D.S. REAGENT SYSTEM

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