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510(k) K163406

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2017
Date Received
December 5, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Esterase--Oxidase, Cholesterol
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
Submission Type

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