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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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21 to 30 of 500 Results *
Analyte Glucose Complexity waived Effective Date To 04/17/2014
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Document Parent Analyte Analyte Specialty Effective Date
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
Jant Pharmacal Corp, LipidPlus Professional Lipid Profile and Glucose Measuring System  
K130295   Glucose monitoring devices (prescription use only) General Chemistry 11/12/2013
LifeScan OneTouch Ultra Blood Glucose Meter  {UniStrip LLC UniStrip1 Test Strips} 
K113135   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/07/2013
LifeScan OneTouch Ultra2 Blood Glucose Meter  {UniStrip LLC UniStrip1 Test Strips} 
K113135   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/07/2013
LifesScan OneTouch UltrasSmart Blood Glucose Monitoring System  {UniStrip LLC UniStrip1 Test Strips} 
K113135   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/07/2013
LifeScan OneTouch UltraMini Blood Glucose Meter  {UniStrip LLC UniStrip1 Test Strips} 
K113135   Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/07/2013

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