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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K971014
Device Name LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
Applicant
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035 -6312
Applicant Contact JUDY MARTIN
Correspondent
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035 -6312
Correspondent Contact JUDY MARTIN
Regulation Number862.1660
Classification Product Code
JJX  
Date Received03/20/1997
Decision Date 04/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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