510(k) K864081

U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST by U. S. Diagnostics, Inc. — Product Code CHH

K864081 is an FDA 510(k) premarket notification submitted by U. S. Diagnostics, Inc. for the device "U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST". The FDA issued a decision of Substantially Equivalent on December 4, 1986. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. U. S. Diagnostics, Inc. has at least 10 other 510(k) clearances on record.