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510(k) K072836

CHOLESTRAK HDL CHOLESTEROL HOME TEST by Accutech, LLC — Product Code LBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2007
Date Received
October 3, 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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