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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K043197
Device Name ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035
Applicant Contact MARY ELLEN HOLDEN
Correspondent
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035
Correspondent Contact MARY ELLEN HOLDEN
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received11/18/2004
Decision Date 05/20/2005
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
Recalls CDRH Recalls
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