GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K073137
Device Name GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
Applicant
APEX BIOTECHNOLOGY CORP.
no. 7, li-hsin road v,
hsinchu science park
hsinchu, 

TW

30078

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

TW

30078

Correspodent Contact thomas y.s. sheen
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received 11/07/2007
Decision Date 04/01/2008
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