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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Glucose monitoring devices (FDA cleared/home use) Complexity waived Effective Date To 10/25/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
All Medicus GlucoDr auto Blood Glucose Test System  
CR140354 K083628 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/17/2014
Wal-Mart Stores, Inc. ReliOn MICRO Blood Glucose Monitoring System  
CR140287 K142035 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/01/2014
Abbott FreeStyle Precision Neo Blood Glucose Monitoring System  
CR140251 K140371 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/01/2014
Roche Diagnostics ACCU-CHEK Performa Blood Glucose Monitoring System  
K133741   Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/30/2014
CERAGEM Medisys Inc. GlucoVitaal H1A Blood Glucose Monitoring System  {Home Use} 
CR140375 K141829 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/25/2014
EosHealth, Inc., In Touch Blood Glucose Monitoring System  
CR140353 K133584 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/25/2014
ACON Laboratories, Inc., On Call Extra Blood Glucose Monitoring System  
CR140306 K132086 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/25/2014
Eps Bio Technology Corp. EasyMax V Self-Monitoring Blood Glucose System  
K092894   Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/05/2014
EPS Bio Technology Corp. EME Pro Self-Monitoring Blood Glucose System  
K112901   Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/03/2014
EPS Bio Technology Corp. EME Self-Monitoring Blood Glucose System  
K112901   Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/03/2014

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