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510(k) K160712

VITROS Chemistry Products hsCRP Reagent by Ortho Clinical Diagnostics — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2017
Date Received
March 15, 2016
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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