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510(k) K120423

BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 by Bionime Corporation — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2012
Date Received
February 13, 2012
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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