510(k) K161837

ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer by Beckman Coulter, Inc. — Product Code JGS

K161837 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer". The FDA issued a decision of Substantially Equivalent on December 16, 2016. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.