FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM


codes

Device Classification Name

glucose oxidase, glucose

510(k) Number K000583
Device Name FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
SELFCARE, INC.
200 prospect st.
waltham, 
MA 
02154 -3457

Original Contact carol a adiletto
Regulation Number 862.1345
Classification Product Code
CGA  
Date Received 02/22/2000
Decision Date 03/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Special
Reviewed by Third Party No

Combination Product

No