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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Glucose Monitoring Devices (FDA Cleared/Home Use) Complexity waived Effective Date To 07/22/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
WEIS PHARMACY BLOOD GLUCOSE SYSTEM  
K992988   Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/22/2001
HEALTH CARE AMERICA BLOOD GLUCOSE SYSTEM  
K992988   Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/22/2001
VALU-RITE BLOOD GLUCOSE SYSTEM  
K992988   Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/22/2001
HUMANA BLOOD GLUCOSE SYSTEM  
K992988   Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/22/2001
KERR BLOOD GLUCOSE SYSTEM  
K992988   Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/13/2000
EXPRESS MED BLOOD GLYCOSE SYSTEM  
K992988   Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/13/2000
DUANE READE BLOOD GLUCOSE SYSTEM  
K992988   Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/13/2000
GOOD NEIGHBOR PHARMACY BLOOD GLUCOSE SYSTEM  
K992988   Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/13/2000
HOME DIAGNOSTICS NAVARRO BLOOD GLUCOSE SYSTEM  
K992988   Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/09/2000
MEIJER BLOOD GLUCOSE SYSTEM  
K992988   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/29/2000

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