MAJOR III BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K072274
Device Name MAJOR III BLOOD GLUCOSE MONITORING SYSTEM
Applicant
BESTGEN BIOTECH CORP.
no. 58 fu chiun street
hsin chu city, 

TW

30067

Applicant Contact jen ke-min
Correspondent
BESTGEN BIOTECH CORP.
no. 58 fu chiun street
hsin chu city, 

TW

30067

Correspodent Contact jen ke-min
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 08/15/2007
Decision Date 02/29/2008
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