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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 K984261
Device Name SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Lifescan, Inc.
700 Thirteenth St., NW
Washington,  DC  20005
Applicant Contact ROGER THIES
Correspondent
Lifescan, Inc.
700 Thirteenth St., NW
Washington,  DC  20005
Correspondent Contact ROGER THIES
Regulation Number862.1345
Classification Product Code
CGA  
Date Received11/27/1998
Decision Date 05/21/1999
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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