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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 K950727
Device Name ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM
Applicant
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035
Applicant Contact JUDY MARTIN
Correspondent
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035
Correspondent Contact JUDY MARTIN
Regulation Number862.1345
Classification Product Code
CGA  
Date Received02/16/1995
Decision Date 06/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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