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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 07/29/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
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
TECO Diagnostics URS-2GP (Glucose Protein) Urine Strips  
K131600   Urine qualitative dipstick glucose Urinalysis 06/02/2014
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
Infopia America, LLC Element Compact Blood Glucose Monitoring System  
K111456   Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/05/2014
EPS Bio Technology Corp EGV1.1 Pro Monitoring Blood Glucose System  
CR140091 K133537 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/30/2014

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