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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 Complexity waived Effective Date To 04/18/2015
 
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Document Parent Analyte Analyte Specialty Effective Date
Nipro Diagnostics True Metrix Air Pro Professional Monitoring Blood Glucose System  
CR150011 K150052 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/03/2015
Nipro Diagnostics True Metrix Air Self Monitoring Blood Glucose System  
CR150011 K150052 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/03/2015
HMD Biomedical, Inc., GoodLife Blood Glucose Monitoring System (Cloudia)  
CR150102 K131173 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/02/2015
BTNX, Inc. Rapid Response Gluco-MD Blood Glucose Monitoring System  
CR150090 K063212 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/20/2015
Roche ACCU-CHEK Aviva Connect Blood Glucose Monitoring System  
CR140259 K141867 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/13/2015
Infopia America, LLC Element Compact V Blood Glucose Monitoring System  
CR140528 K133260 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/20/2015
Infopia America, LLC Element Compact V Multi Blood Glucose Monitoring System  
CR140528 K133260 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/20/2015
Clarity Diagnostics LLC, Clarify 10SG Urine Reagent Strips  
CR140504 K061559 Urine qualitative dipstick glucose Urinalysis 12/29/2014
Clarity Diagnostics LLC, Clarify U122 Urine Analyzer  
CR140503 K070929 Urine qualitative dipstick glucose Urinalysis 12/29/2014
Arkray USA, Inc. GLUCOCARD Shine Blood Glucose Monitoring System  
CR140380 K120351 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/24/2014

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