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510(k) K113830

VANTERA CLINICAL ANALYZER by Liposcience — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2012
Date Received
December 27, 2011
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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