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510(k) K041155

WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY by Stanbio Laboratory — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2004
Date Received
May 3, 2004
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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