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510(k) K050836

CRP DIAGNOSTIC ASSAY by Sentinel Ch. Srl — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2005
Date Received
April 1, 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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Other clearances for product code DCK

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