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510(k) K062981

I-CHROMA CRP TEST by Boditech Diagnostics, Inc. — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2007
Date Received
September 29, 2006
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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