ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM


the company

Device Classification Name

glucose oxidase, glucose

510(k) Number K002134
Device Name ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
SELFCARE, INC.
200 prospect st.
waltham, 
MA 
02154 -3457

Original Contact carol a adiletto, m.s.
Regulation Number 862.1345
Classification Product Code
CGA  
Date Received 07/14/2000
Decision Date 08/07/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Special
Reviewed by Third Party No

Combination Product

No