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510(k) K152328

FreeStyle InsuLinx Blood Glucose Monotioring System by Abott Laboratories — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2015
Date Received
August 18, 2015
Clearance Type
Special
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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