510(k) K780638

ACCESSORY HDL CHOLESTEROL REAGENT SET by The Dow Chemical Co. — Product Code CHH

K780638 is an FDA 510(k) premarket notification submitted by The Dow Chemical Co. for the device "ACCESSORY HDL CHOLESTEROL REAGENT SET". The FDA issued a decision of Substantially Equivalent on May 26, 1978. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. The Dow Chemical Co. has at least 10 other 510(k) clearances on record.