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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
Original Applicant
CILAG GMBH INTERNATIONAL
landis and gyr strasse 1
zug,  SZ 6300
Original 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 - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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