FORA POCT MANAGMENT SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K111029
Device Name FORA POCT MANAGMENT SYSTEM
Applicant
TaiDoc Technology Corporation
3f,5f, no.127 wugong 2nd rd.
wugu township
taipei county, 

TW

24888

Applicant Contact teling hsu
Correspondent
TaiDoc Technology Corporation
3f,5f, no.127 wugong 2nd rd.
wugu township
taipei county, 

TW

24888

Correspodent Contact teling hsu
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received 04/13/2011
Decision Date 07/01/2011
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