FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K111890
Device Name FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM
Applicant
TaiDoc Technology Corporation
3f,5f, no.127 wugong 2nd rd,
wugu district
new taipei city, 

TW

24888

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

TW

24888

Correspodent Contact meiru li
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received 07/01/2011
Decision Date 02/06/2012
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