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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 K984006
Device Name GLUCOMETER ELITE XL BLOOD GLUCOSE METER
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 Received11/10/1998
Decision Date 03/18/1999
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
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