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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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31 to 40 of 500 Results *
Analyte Glucose Complexity waived Effective Date To 04/21/2014
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Document Parent Analyte Analyte Specialty Effective Date
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
Nova Biomedical FOCUS PRO Blood Glucose Monitoring System  
K131013   Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/18/2013
AgaMatrix CareOne Value Blood Glucose Monitoring System  
K073573   Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/18/2013
Gluco Perfect L.L.C., Perfect 3 Blood Glucose Monitoring System Model 6267-S  
K122525   Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013
Gluco Perfect L.L.C., Perfect 3 Multi Blood Glucose Monitoring System Model 6267-M  
K122525   Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013

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