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510(k) K072395

DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS by Diazyme Laboratories — Product Code LBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2008
Date Received
August 27, 2007
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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