510(k) K130122

BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER by Beckman Coulter, Inc. — Product Code CFN

K130122 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER". The FDA issued a decision of Substantially Equivalent on January 7, 2014. 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.