510(k) K002799

PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 by Beckman Coulter, Inc. — Product Code CFF

K002799 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100". The FDA issued a decision of Substantially Equivalent on October 5, 2000. The device falls under product code CFF (Immunoelectrophoretic, 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.