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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K131363
Device Name ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
Applicant
CILAG GMBH INTERNATIONAL
GUBELSTRASSE 34
ZUG,  CH 6300
Applicant Contact Oyinkan Donaldson
Correspondent
CILAG GMBH INTERNATIONAL
GUBELSTRASSE 34
ZUG,  CH 6300
Correspondent Contact Oyinkan Donaldson
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received05/13/2013
Decision Date 08/30/2013
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
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