510(k) K891922

AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325 by American Research Products Co. — Product Code CHH

K891922 is an FDA 510(k) premarket notification submitted by American Research Products Co. for the device "AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325". The FDA issued a decision of Substantially Equivalent on June 16, 1989. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. American Research Products Co. has at least 10 other 510(k) clearances on record.