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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
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