510(k) K220977

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. — Product Code JGS

K220977 is an FDA 510(k) premarket notification submitted by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. for the device "ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer". The FDA issued a decision of Substantially Equivalent on July 20, 2023. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. has at least 1 other 510(k) clearance on record.