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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK113135
Test Name LifeScan OneTouch Ultra Blood Glucose Meter  {UniStrip LLC UniStrip1 Test Strips} 
Manufacturer NameUnistrip Technologies, LLC
Consumer Information Phone Number(888)729-9674
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date11/07/2013
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K113135
Device Name UNISTRIP 1
Applicant
Unistrip Technologies, LLC
1468 Harwell Ave.
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Unistrip Technologies, LLC
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received10/24/2011
Decision Date 11/06/2013
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
Predetermined Change
Control Plan Authorized		 No
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