AG-608N BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K110017
Device Name AG-608N BLOOD GLUCOSE MONITORING SYSTEM
Applicant
ANDON MEDICAL CO., LTD.
no. 04-23-3 airport industrial
park, tianjin
tianjin, 

CN

300381

Applicant Contact yi liu
Correspondent
ANDON MEDICAL CO., LTD.
no. 04-23-3 airport industrial
park, tianjin
tianjin, 

CN

300381

Correspodent Contact yi liu
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received 01/03/2011
Decision Date 01/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01268345
Reviewed by Third Party No

Combination Product

No