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510(k) K052591

NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT by Clinical Data, Inc. — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2006
Date Received
September 21, 2005
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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