510(k) K022690

PAROS CRP by Horiba, Ltd. — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2002
Date Received
August 13, 2002
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