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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
Original Applicant
BAYER CORP.
1884 miles ave.
p.o. box 70
elkhart,  IN  46515 -0070
Original 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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