ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K072543
Device Name ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
Applicant
LIFESCAN, INC.
1000 gibraltar dr.
milpitas, 
CA 
95035 -6312

Applicant Contact alison wilson
Correspondent
LIFESCAN, INC.
1000 gibraltar dr.
milpitas, 
CA 
95035 -6312

Correspodent Contact alison wilson
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 09/10/2007
Decision Date 10/05/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls