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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 K991242
Device Name GLUCOMETER ELITE TEST STRIPS
Applicant
Bayer Corp.
1884 Miles Ave.
Elkhart,  IN  46514
Applicant Contact GEORGE M TANCOS
Correspondent
Bayer Corp.
1884 Miles Ave.
Elkhart,  IN  46514
Correspondent Contact GEORGE M TANCOS
Regulation Number862.1345
Classification Product Code
CGA  
Date Received04/12/1999
Decision Date 06/30/1999
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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