RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K110737
Device Name RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700
Applicant
BIONIME CORPORATION
55 northern blvd. suite 200
great neck, 
NY 
11021

Applicant Contact jigar shah
Correspondent
BIONIME CORPORATION
55 northern blvd. suite 200
great neck, 
NY 
11021

Correspodent Contact jigar shah
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received 03/16/2011
Decision Date 03/29/2012
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