COMBI-SCREEN, MODELS 10SL AND 11SL


Device Classification Name

method, enzymatic, glucose (urinary, non-quantitative)

510(k) Number K023885
Device Name COMBI-SCREEN, MODELS 10SL AND 11SL
Original Applicant
ANALYTICON BIOTECHNOLOGIES AG
p.o. box 7007
deerfield, 
IL 
60015

Original Contact daniel kamm
Regulation Number 862.1340
Classification Product Code
JIL  
Subsequent Product Code
JIP  
Date Received 11/21/2002
Decision Date 10/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No