ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
K-Number: K161837 · 2016-12-16
ApplicantBeckman Coulter, Inc.
Decision Date2016-12-16
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2016-12-16 under approval number K161837. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer?
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K161837.
When was ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer approved by the FDA?
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer received FDA 510(k) clearance on 2016-12-16, under approval number K161837.
What company makes ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer?
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer is manufactured by Beckman Coulter, Inc..
What is the FDA product code for ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer?
The FDA product code for ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer is JGS.
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Official Source
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