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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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91 to 100 of 500 Results *
Analyte Glucose Complexity waived Effective Date To 10/22/2014
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Document Parent Analyte Analyte Specialty Effective Date
Infopia Co., Ltd. GluNEO Professional Blood Glucose Monitoring System  {Professional Use} 
K130181   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/01/2013
Major Biosystem Corp. AP-2000 Blood Glucose Monitoring System  
K103116   Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/19/2013
Major Biosystem Corp. AP-2000multi Blood Glucose Monitoring System  
K103116   Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/19/2013
Major Biosystem Corp. AP-2010 Blood Glucose Monitoring System  
K103116   Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/19/2013
Major Biosystem Corp. AP-2010multi Blood Glucose Monitoring System  
K103116   Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/19/2013
Major Biosystem Corp. AP-2020 Blood Glucose Monitoring System  
K103116   Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/19/2013
Major Biosystem Corp. AP-2020multi Blood Glucose Monitoring System  
K103116   Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/19/2013
Fora Care, Foracare GD20 Blood Glucose Monitoring System  
K124040   Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/12/2013
Bayer Contour Next USB Blood Glucose Monitoring System  
K121087   Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/12/2013
OPTUMRx Blood Glucose Monitoring System  
K090057   Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/12/2013

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