RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K081451
Device Name RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100
Applicant
BIONIME CORPORATION
55 northern blvd. suite 200
great neck, 
NY 
11021

Applicant Contact susan d goldstein-falk
Correspondent
BIONIME CORPORATION
55 northern blvd. suite 200
great neck, 
NY 
11021

Correspodent Contact susan d goldstein-falk
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 05/23/2008
Decision Date 09/18/2008
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