CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K073119
Device Name CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
TaiDoc Technology Corporation
4f, 88, sec.1, kwang fu road
san chung, taipei, 

TW

241

Applicant Contact erica li
Correspondent
TaiDoc Technology Corporation
4f, 88, sec.1, kwang fu road
san chung, taipei, 

TW

241

Correspodent Contact erica li
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 11/05/2007
Decision Date 03/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No