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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 K093745
FOIA Releasable 510(k) K093745
Device Name ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
Applicant
LIFESCAN, INC.
1000 GIBRALTAR DR., MS 2C
MILPITAS,  CA  95035 -6312
Applicant Contact LISA MCGRATH
Correspondent
LIFESCAN, INC.
1000 GIBRALTAR DR., MS 2C
MILPITAS,  CA  95035 -6312
Correspondent Contact LISA MCGRATH
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received12/04/2009
Decision Date 02/11/2011
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
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