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510(k) K111874

FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS by Abbott Laboratories — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2012
Date Received
July 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Dehydrogenase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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