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510(k) K151164

Assure Prism multi Blood Glucose Monitoring System by I-Sens, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2015
Date Received
May 1, 2015
Clearance Type
Special
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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