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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 K132511
Model 71411-70
Device Name FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
Original Applicant
ABBOTT DIABETES CARE INC.
1360 south loop rd.
alameda,  CA  94502
Original Contact vrusahli tembe
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JIN   JQP   LFR  
Date Received08/12/2013
Decision Date 12/24/2013
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
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