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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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51 to 60 of 500 Results *
Analyte Glucose Complexity waived Effective Date To 07/28/2014
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Document Parent Analyte Analyte Specialty Effective Date
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
Fora Care Fora Diamond Prima Blood Glucose Monitoring System   
K111890   Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013
Fora Care Fora Diamond Mini Blood Glucose Monitoring System   
K111890   Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013
FORA CARE TD-4239 BLOOD GLUCOSE MONITORING SYSTEM  
K101635   Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013
FORA CARE TD-4239 multi BLOOD GLUCOSE MONITORING SYSTEM  
K101635   Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013
AgaMatrix CareOne Premium Blood Glucose Monitoring System  
K072413   Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013

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