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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 K023584
Device Name ASCENSIA DEX 2 DIABETES CARE SYSTEM
Applicant
BAYER CORP.
1884 MILES AVE.
P.O. BOX 70
ELKHART,  IN  46515 -0070
Applicant Contact GEORGE M TANCROS
Correspondent
BAYER CORP.
1884 MILES AVE.
P.O. BOX 70
ELKHART,  IN  46515 -0070
Correspondent Contact GEORGE M TANCROS
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received10/25/2002
Decision Date 11/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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