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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 K001441
Device Name SATURN BLOOD GLUCOSE MONITORING TEST STRIP
Applicant
LIFESCAN, INC.
1000 GIBRALTAR DR.
MILPITAS,  CA  95035 -6312
Applicant Contact MARY ELLEN HOLDEN
Correspondent
LIFESCAN, INC.
1000 GIBRALTAR DR.
MILPITAS,  CA  95035 -6312
Correspondent Contact MARY ELLEN HOLDEN
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received05/08/2000
Decision Date 12/18/2000
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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