EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K110435
Device Name EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
Applicant
US DIAGNOSTICS, INC.
304 park avenue south
suite 218
new york, 
NY 
10010 -4301

Applicant Contact jonathan johnson
Correspondent
US DIAGNOSTICS, INC.
304 park avenue south
suite 218
new york, 
NY 
10010 -4301

Correspodent Contact jonathan johnson
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 02/15/2011
Decision Date 09/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No