CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K081144
Device Name CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243
Applicant
TaiDoc Technology Corporation
6f, no. 127, wugong 2nd rd
wugu township
taipei county, 

TW

248

Applicant Contact yuhua chen
Correspondent
TaiDoc Technology Corporation
6f, no. 127, wugong 2nd rd
wugu township
taipei county, 

TW

248

Correspodent Contact yuhua chen
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received 04/22/2008
Decision Date 06/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No