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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 K120558
Device Name ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
Original Applicant
LIFESCAN, INC.
200 lawrence drive
mailstop c-2-2
west chester,  PA  19380
Original Contact andrea tasker
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received02/24/2012
Decision Date 02/07/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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