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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Glucose Complexity waived Effective Date To 09/02/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Bionime Corporation Rightest Blood Glucose Monitoring System GS720  
K140210   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2014
Bionime Corporation Rightest Professional Blood Glucose Monitoring System GS720  
K140210   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2014
OK Biotech Co., Ltd. OKmeter Direct Blood Glucose Monitoring System  
K132633   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/14/2014
Medline 120 Urine Analyzer  
CR140245 K070929 Urine qualitative dipstick glucose Urinalysis 08/08/2014
ARKRAY USA, Inc. Assure Prism Multi Blood Glucose Monitoring System  
CR140257 K131419 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/07/2014
Medline Urinalysis Reagent Strips  
CR140244 K061559 Urine qualitative dipstick glucose Urinalysis 08/07/2014
Philosys Gmate SMART Blood Glucose Monitoring System  
K131230   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/05/2014
Tianjin Empecs Medisign MM3000 Blood Glucose Monitoring System  
K133260   Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/01/2014
Tianjin Empecs Medisign MM3000 Multi Blood Glucose Monitoring System  
K133260   Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/01/2014
IDEAL LIFE GlucoManager Blood Glucose Monitoring System, Model GMM0002  
K132180   Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/30/2014

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