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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Dehydrogenase, Glucose
510(k) Number K152328
Device Name FreeStyle InsuLinx Blood Glucose Monotioring System
Applicant
ABOTT LABORATORIES
1360 SOUTH LOOP ROAD
ALAMEDA,  CA  94502
Applicant Contact SAI SRIHARSHADA TATAVARTY
Correspondent
ABBOTT LABORATORIES
1360 SOUTH LOOP ROAD
ALAMEDA,  CA  94502
Correspondent Contact Sai Sriharshada Tatavarty
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received08/18/2015
Decision Date 09/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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