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510(k) K150654

Cholesterol by Randox Laboratories, Ltd. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2015
Date Received
March 13, 2015
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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