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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 10 of 500 Results *
Analyte Glucose Monitoring Devices (FDA Cleared/Home Use) Complexity waived Effective Date To 04/16/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Nipro Diagnostics, Inc. TRUE FOCUS Blood Glucose Monitoring System  
K131013   Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/21/2014
Nipro Diagnostics, Inc. TRUE FOCUS PRO Blood Glucose Monitoring System  
K131013   Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/21/2014
Infopia USA, LLC. Healthpro Professional Blood Glucose Monitoring System  
K132862   Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/19/2014
Omnis Health Embrace EVO Blood Glucose Monitoring System  
K113208   Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/18/2014
Apex BioTechnology Corp. AutoSure HT Blood Glucose Monitoring System  
K131750   Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/10/2014
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

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