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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 K923544
Device Name ONE TOUCH TEST STRIPS
Applicant
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035
Applicant Contact JOHN E HUGGHES
Correspondent
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035
Correspondent Contact JOHN E HUGGHES
Regulation Number862.1345
Classification Product Code
CGA  
Date Received07/16/1992
Decision Date 12/03/1992
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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