510(k) K963018

BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS by Bio-Rad — Product Code CEF

K963018 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS". The FDA issued a decision of Substantially Equivalent on June 4, 1997. The device falls under product code CEF (Electrophoretic, Protein Fractionation), a Class I device regulated under 21 CFR 862.1630. Bio-Rad has at least 10 other 510(k) clearances on record.