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510(k) K142985

UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator by Beckman Coulter, Inc. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2015
Date Received
October 16, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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