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510(k) K122126

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR by Randox Laboratories Limited — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2012
Date Received
July 18, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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