510(k) K771812

LIPPOPROTEIN ELECTROPHORESIS REAGENT SET by Gelman Instrument Co. — Product Code DFC

K771812 is an FDA 510(k) premarket notification submitted by Gelman Instrument Co. for the device "LIPPOPROTEIN ELECTROPHORESIS REAGENT SET". The FDA issued a decision of Substantially Equivalent on October 18, 1977. The device falls under product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5600. Gelman Instrument Co. has at least 10 other 510(k) clearances on record.