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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K020210
Device Name GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)
Applicant
Bayer Group Diagnostics
1884 Miles Ave.
P.O. Box 70
Elkhart,  IN  46515
Applicant Contact GEORGE M TANCOS
Correspondent
Bayer Group Diagnostics
1884 Miles Ave.
P.O. Box 70
Elkhart,  IN  46515
Correspondent Contact GEORGE M TANCOS
Regulation Number862.1345
Classification Product Code
NBW  
Date Received01/22/2002
Decision Date 04/30/2002
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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