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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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61 to 70 of 500 Results *
Analyte Glucose Complexity waived Effective Date To 07/25/2014
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Document Parent Analyte Analyte Specialty Effective Date
DELBio Incorporation DiaTrue Plus Blood Glucose Monitoring System  
K130244   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/27/2013
DolgenCorp Rexall Blood Glucose Monitoring System  
K073573   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/26/2013
I-Sens, Inc. ACURA PLUS Multi Blood Glucose Monitoring System  
K131419   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
i-SENS, Inc. CareSens N LINK Blood Glucose Monitoring System  
K130696   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
i-SENS, Inc. CareSens N LINK Multi Blood Glucose Monitoring System  
K130696   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
Visgeneer, Inc. eBchek Blood Glucose Monitoring System  
K122181   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
DELBio DiaTrue Plus Blood Glucose Monitoring System  
K103329   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
Hygieia, Inc. BaseSens I Blood Glucose Monitoring System  
K093475   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
Diabetes Care Club, Rightest GM250S Blood Glucose Monitoring System  
K092052   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
Tyson Bioresearch, Inc., Guardian TB100 Blood Glucose Monitoring System  
K073492   Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013

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