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510(k) K111516

NMR LIPOPROFILE (R) TEST AND NMR PROFILER by Liposcience, Inc. — Product Code LBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2011
Date Received
June 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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