K-number	K162208
Device name	DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
Applicant	Beckman Coulter, Inc.
Product code	CFN
Device class	Class II
Decision date	Jan 9, 2017
Decision	Substantially Equivalent
Regulation	866.5510

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Source

View the full FDA submission: accessdata.fda.gov

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DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent

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