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510(k) K181373

Extended Lipid Panel Assay by Laboratory Corporation of America Holdings — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2018
Date Received
May 24, 2018
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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