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510(k) K032336

TINA-QUANT CRP (LATEX) by Roche Diagnostics Corp. — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2003
Date Received
July 29, 2003
Clearance Type
Special
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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