Name: Predicase
Price: 199 USD

K-number	K161837
Device name	ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
Applicant	Beckman Coulter, Inc.
Product code	JGS
Device class	Class II
Decision date	Dec 16, 2016
Decision	Substantially Equivalent
Regulation	862.1665

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Source

View the full FDA submission: accessdata.fda.gov

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ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer

Everything you need for a 510(k) submission. Nothing you don't.