EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP


Device Classification Name

glucose oxidase, glucose

510(k) Number K991480
Device Name EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
Applicant
SELFCARE, INC.
200 prospect st.
waltham, 
MA 
02154 -3457

Applicant Contact carol adiletto
Correspondent
SELFCARE, INC.
200 prospect st.
waltham, 
MA 
02154 -3457

Correspodent Contact carol adiletto
Regulation Number 862.1345
Classification Product Code
CGA  
Date Received 04/28/1999
Decision Date 09/17/1999
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