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510(k) K161691

Direct LDL Cholesterol (LDL) by Randox Laboratories Limited — Product Code MRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2017
Date Received
June 20, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Low Density, Lipoprotein
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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