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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 K151611
Device Name OneTouch Ultra Plus Flex Blood Glucose Monitoring System
Applicant
Lifescan Europe
Gubelstrasse 34
Zug,  CH Ch-6300
Applicant Contact NIKI SKELLY
Correspondent
Lifescan Scotland, Ltd.
Beechwood Park N.
Inverness,  GB iv2 3ed
Correspondent Contact NIKI SKELLY
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received06/15/2015
Decision Date 12/14/2015
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
Predetermined Change
Control Plan Authorized		 No
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