3TEST SUPREME GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K072905
Device Name 3TEST SUPREME GLUCOSE MONITORING SYSTEM
Applicant
NEUERO ENGINEERING INC.
no 58, fu-chiun street
hsin-chu city, 

TW

30067

Applicant Contact ke-min jen
Correspondent
NEUERO ENGINEERING INC.
no 58, fu-chiun street
hsin-chu city, 

TW

30067

Correspodent Contact ke-min jen
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 10/11/2007
Decision Date 04/18/2008
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