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510(k) K032663

QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 by Instrumentation Laboratory CO — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2003
Date Received
August 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

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