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510(k) K121558

DIAZYME HSCRP POC TEST KIT by Diazyme Laboratories — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2012
Date Received
May 29, 2012
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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