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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 08/21/2014
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Document Parent Analyte Analyte Specialty Effective Date
EPS Bio Technology Corp EMV3.1 Self-Monitoring Blood Glucose System  
K133647   Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/19/2014
EPS Bio Technology Corp EMV3.1 Pro Blood Glucose System  
K133647   Glucose monitoring devices (prescription use only) General Chemistry 02/19/2014
Easy at Home Medical, Areta Urinalysis Reagent Strips  
K061559   Urine qualitative dipstick glucose Urinalysis 02/10/2014
SD BioSensor, Inc. SD GlucoMentor Blood Glucose Monitoring System  
K123517   Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/24/2014
SD BioSensor, Inc. SD GlucoMentor Multi Blood Glucose Monitoring System  
K123517   Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/24/2014
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

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