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510(k) K103557

DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET by Diazyme Laboratories — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2011
Date Received
December 2, 2010
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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