ASCENSIA DEX 2 DIABETES CARE SYSTEM


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 Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 10/25/2002
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