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510(k) K131419

ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM by I-Sens, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2013
Date Received
May 16, 2013
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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