FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K112275
Device Name FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
TaiDoc Technology Corporation
3f,5f, no.127 wugong 2nd rd,
wugu district
new taipei city, 

TW

24888

Applicant Contact linda ko
Correspondent
TaiDoc Technology Corporation
3f,5f, no.127 wugong 2nd rd,
wugu district
new taipei city, 

TW

24888

Correspodent Contact linda ko
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 08/08/2011
Decision Date 12/15/2011
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