FDA 510(k), K163406, Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System

FDA 510(k), K163406, Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System

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510(K) Number: K163406
Device Name: Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
Manufacturer: ACON LABORATORIES INC.
Device Classification Name: Enzymatic Esterase--Oxidase, Cholesterol
Regulation Number: 862.1175
Classification Product Code: CHH
Date Received: 12/05/2016
Decision Date: 07/11/2017
Regulation Medical Specialty: Clinical Chemistry

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