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510(k) K150819

Triglycerides by Randox Laboratories Limited — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2015
Date Received
March 27, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

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