GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1


Device Classification Name

glucose oxidase, glucose

510(k) Number K073648
Device Name GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1
Applicant
APEX BIOTECHNOLOGY CORP.
no. 7, li-hsin road v,
hsinchu science park
hsinchu, 

TW

30078

Applicant Contact thomas y.s. shen
Correspondent
APEX BIOTECHNOLOGY CORP.
no. 7, li-hsin road v,
hsinchu science park
hsinchu, 

TW

30078

Correspodent Contact thomas y.s. shen
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received 12/26/2007
Decision Date 04/10/2008
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