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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 K073231
Device Name ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
LIFESCAN, INC.
1000 gibraltar dr.
milpitas,  CA  95035 6312
Original Contact kim fonda
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received11/15/2007
Decision Date 04/18/2008
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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