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510(k) K053635

MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM by Bionime Corporation — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2006
Date Received
December 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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