510(k) K162208

DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent by Beckman Coulter, Inc. — Product Code CFN

K162208 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent". The FDA issued a decision of Substantially Equivalent on January 9, 2017. The device falls under product code CFN (Method, Nephelometric, Immunoglobulins (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.