FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS


Device Classification Name

glucose dehydrogenase, glucose

510(k) Number K111874
Device Name FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
Applicant
ABBOTT LABORATORIES
1360 south loop road
alameda, 
CA 
94502

Applicant Contact arul sterlin
Correspondent
ABBOTT LABORATORIES
1360 south loop road
alameda, 
CA 
94502

Correspodent Contact arul sterlin
Regulation Number 862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received 07/01/2011
Decision Date 02/16/2012
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