510(k) K813039

ULTRACHEM E-CHOL, ITEM #65025 by Harleco — Product Code CHH

K813039 is an FDA 510(k) premarket notification submitted by Harleco for the device "ULTRACHEM E-CHOL, ITEM #65025". The FDA issued a decision of Substantially Equivalent on November 10, 1981. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Harleco has at least 10 other 510(k) clearances on record.