510(k) K180504

Mission Lipid Panel Monitoring System by ACON Laboratories, Inc. — Product Code CHH

K180504 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "Mission Lipid Panel Monitoring System". The FDA issued a decision of Substantially Equivalent on March 28, 2018. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.