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510(k) K130094

FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM by Abbott Diabetes Care — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2013
Date Received
January 10, 2013
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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