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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K120568
Model 71142-70, 71143-70 71150-70
Device Name FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
ABBOTT DIABETES CARE INC.
1360 south loop rd.
alameda,  CA  94502
Original Contact arul sterlin
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received02/29/2012
Decision Date 03/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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