ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

glucose dehydrogenase, glucose

510(k) Number K110637
Device Name ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
Applicant
CILAG GMBH INTERNATIONAL
landis and gyr strasse 1
zug, 

CH

6300

Applicant Contact fiona leeper
Correspondent
CILAG GMBH INTERNATIONAL
landis and gyr strasse 1
zug, 

CH

6300

Correspodent Contact fiona leeper
Regulation Number 862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received 03/04/2011
Decision Date 09/07/2011
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

Recalls CDRH Recalls