ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K021819
Device Name ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
LIFESCAN, INC.
1000 gibraltar dr.
milpitas, 
CA 
95035 -6312

Original Contact mary ellen holden
Regulation Number 862.1345
Classification Product Code
NBW  
Date Received 06/04/2002
Decision Date 08/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls