CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K073494
Device Name CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING
Applicant
TaiDoc Technology Corporation
6f, no. 127, wugong 2nd rd
wugu township
taipei county, 

TW

248

Applicant Contact yuhua chen
Correspondent
TaiDoc Technology Corporation
6f, no. 127, wugong 2nd rd
wugu township
taipei county, 

TW

248

Correspodent Contact yuhua chen
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 12/12/2007
Decision Date 04/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No