DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K080853
Device Name DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM
Applicant
GENEXEL-SEIN, INC.
845 aronson lake court
roswell, 
GA 
30075

Applicant Contact jay mansour
Correspondent
GENEXEL-SEIN, INC.
845 aronson lake court
roswell, 
GA 
30075

Correspodent Contact jay mansour
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   DXN   JJX  
Date Received 03/26/2008
Decision Date 02/20/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No