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510(k) K113809

HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) by Hitachi Chemical Diagnostics, Inc. — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2012
Date Received
December 23, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

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