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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 K021819
Device Name ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
LIFESCAN, INC.
1000 gibraltar dr.
milpitas,  CA  95035 -6312
Original Contact mary ellen holden
Regulation Number862.1345
Classification Product Code
NBW  
Date Received06/04/2002
Decision Date 08/23/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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