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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK150214
Test Name LifeScan OneTouch Verio Flex Blood Glucose Monitoring System  
Manufacturer NameLifescan Europe
Consumer Information Phone Number1(888)567-3003
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date08/03/2015
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K150214
Device Name OneTouch Verio Flex Blood Glucose Monitoring System
Applicant
Lifescan Europe
Gubelstrasse 34
Zug,  CH Ch-6300
Applicant Contact Alison Wilson
Correspondent
Lifescan Scotland, Ltd.
Beechwood Park N.
Inverness,  GB iv2 3ed
Correspondent Contact Alison Wilson
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received01/30/2015
Decision Date 07/31/2015
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
Predetermined Change
Control Plan Authorized		 No
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