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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 07/28/2014
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Document Parent Analyte Analyte Specialty Effective Date
Acon Laboratories, Inc. On Call Sharp Blood Glucose Monitoring System  
K130284   Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/30/2013
Kmart SmartSense Value Blood Glucose Monitoring System  
K073573   Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/24/2013
Kmart SmartSense Premium Blood Glucose Monitoring System  
K072413   Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/24/2013
On Call Express Blood Glucose Monitoring System  
K132086   Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/20/2013
Infopia Co., Ltd. GluNEO Lite Blood Glucose Monitoring System  
K132966   Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/09/2013
Infopia Co., Ltd. GluNEO Lite Professional Blood Glucose Monitoring System  
K132966   Glucose monitoring devices (prescription use only) General Chemistry 12/09/2013
Prodigy Choice Blood Glucose Monitoring System  
K122340   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/27/2013
i-SENS, Inc. CareSens N Voice Multi Blood Glucose Monitoring System  
K132288   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/25/2013
General Life Biotechnology Co., Ltd., BeneCheck Premium GLU Monitoring System  
K123090   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/25/2013
General Life Biotechnology Co., Ltd., BeneCheck Premium PRO GLU Monitoring System  
K123090   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/25/2013

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