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510(k) K061182

CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB by Cliniqa Corporation — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2006
Date Received
April 27, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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