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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 K053529
Device Name ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
LIFESCAN, INC.
1000 gibraltar dr.
milpitas,  CA  95035 6312
Original Contact lisa mcgrath
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received12/19/2005
Decision Date 01/17/2006
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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