ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K081318
Device Name ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
Applicant
LIFESCAN, INC.
1000 gibraltar dr.
milpitas, 
CA 
95035 -6312

Applicant Contact frank peralta
Correspondent
LIFESCAN, INC.
1000 gibraltar dr.
milpitas, 
CA 
95035 -6312

Correspodent Contact frank peralta
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received 05/12/2008
Decision Date 06/09/2008
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