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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 K111874
Device Name FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
Applicant
ABBOTT LABORATORIES
1360 SOUTH LOOP ROAD
ALAMEDA,  CA  94502
Applicant Contact ARUL STERLIN
Correspondent
ABBOTT LABORATORIES
1360 SOUTH LOOP ROAD
ALAMEDA,  CA  94502
Correspondent Contact ARUL STERLIN
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received07/01/2011
Decision Date 02/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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