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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 09/20/2014
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Document Parent Analyte Analyte Specialty Effective Date
MHC Medical Products, LLC. Easy Touch® HealthPro Glucose Monitoring System  
K113192   Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/10/2014
CERAGEM Medisys Inc. CERA-CHEK 1070 Blood Glucose Monitoring System  {Home Use} 
K131727   Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/04/2014
Home Aide Diagnostics, Inc., Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M  
K133509   Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/21/2014
Progressive Health Supply & Source Corp. Smartest Persona II Blood Glucose Monitoring System Model 6276-S  
K133509   Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/21/2014
Progressive Health Supply & Source Corp. Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M  
K133509   Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/21/2014
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

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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