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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 08/20/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
OK Biotech Co., Ltd. OKmeter Direct Blood Glucose Monitoring System  
K132633   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/14/2014
ARKRAY USA, Inc. Assure Prism Multi Blood Glucose Monitoring System  
CR140257 K131419 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/07/2014
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
Andon iHealth Align Mini Gluco-Monitoring System  
K133790   Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/27/2014
Biotest Medical Corporation, SuperCheck 1 Blood Glucose Monitoring System, Model 6267  
K122525   Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/20/2014
Medline Industries, Inc. EvenCare G3 Professional Blood Glucose Monitoring System  
K120448   Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/16/2014
CVS/Pharmacy Advanced Blood Glucose Monitoring System  
CR140076 K072413 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/12/2014

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