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510(k) K062916

CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 by Cliniqa Corporation — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2006
Date Received
September 28, 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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  • K052679 — CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN (November 18, 2005)

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