AG-605 BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K073030
Device Name AG-605 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
ANDON HEALTH CO.,LTD
ya an rd nankai district
tiajin, 

CN

300190

Applicant Contact ms. mona
Correspondent
ANDON HEALTH CO.,LTD
ya an rd nankai district
tiajin, 

CN

300190

Correspodent Contact ms. mona
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received 10/26/2007
Decision Date 07/21/2008
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