K-number	K851541
Device name	DART IMMUNOGLOBULINS REAGENT SYSTEM
Applicant	Coulter Electronics, Inc.
Product code	DEW
Device class	Class II
Decision date	Jul 15, 1985
Decision	Substantially Equivalent
Regulation	866.5510

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View the full FDA submission: accessdata.fda.gov

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DART IMMUNOGLOBULINS REAGENT SYSTEM

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