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510(k) K080973

CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC by Cliniqa Corporation — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2008
Date Received
April 4, 2008
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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  • K052679 — CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN (November 18, 2005)

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