510(k) K163406

Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System by ACON Laboratories, Inc. — Product Code CHH

K163406 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System". The FDA issued a decision of Substantially Equivalent on July 11, 2017. 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.