FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K103487
Device Name FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
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 862.1155
Classification Product Code
LCX  
Date Received 11/26/2010
Decision Date 10/04/2011
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