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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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61 to 70 of 500 Results *
Analyte Glucose Complexity waived Effective Date To 10/21/2014
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Document Parent Analyte Analyte Specialty Effective Date
LifeScan OneTouch Ultra Blood Glucose Meter  {UniStrip LLC UniStrip1 Test Strips} 
K113135   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/07/2013
LifeScan OneTouch Ultra2 Blood Glucose Meter  {UniStrip LLC UniStrip1 Test Strips} 
K113135   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/07/2013
LifesScan OneTouch UltrasSmart Blood Glucose Monitoring System  {UniStrip LLC UniStrip1 Test Strips} 
K113135   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/07/2013
LifeScan OneTouch UltraMini Blood Glucose Meter  {UniStrip LLC UniStrip1 Test Strips} 
K113135   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/07/2013
Prodigy Diabetes Care, LLC Prodigy Preferred Blood Glucose Monitoring System  
K122338   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/06/2013
Omnis Health Embrace Pro Blood Glucose Monitoring System  
K083628   Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/24/2013
Roche Diagnostics Accu-Chek Aviva Expert Blood Glucose Monitoring System  
K131366   Glucose monitoring devices (prescription use only) General Chemistry 10/22/2013
Fora Care Inc, TD-4268 Blood Glucose Monitoring System  
K120042   Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/21/2013
Fora Care Inc, TD-4268 Multi Blood Glucose Monitoring System  
K120042   Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/21/2013
Nova Biomedical FOCUS Blood Glucose Monitoring System  
K131013   Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/18/2013

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