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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact FIONA LEEPER
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received03/04/2011
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
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