510(k) K232404

CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES by Medicon Hellas S.A — Product Code CHH

K232404 is an FDA 510(k) premarket notification submitted by Medicon Hellas S.A for the device "CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES". The FDA issued a decision of Substantially Equivalent on August 9, 2024. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Medicon Hellas S.A has at least 2 other 510(k) clearances on record.