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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 8 of 8 Results
Analyte Ketone, Blood Complexity waived Effective Date To 08/30/2014
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Document Parent Analyte Analyte Specialty Effective Date
Abbott Freestyle precision pro blood glucose and beta-ketone monitoring system  
K130094   Ketone, blood General Chemistry 07/01/2013
Nova Biomedical Nova Max Mini Glucose and B-Ketone Monitoring System  
K122688   Ketone, blood General Chemistry 04/16/2013
Nova Biomedical Nova Max Plus Glucose and B-Ketone Monitoring System  
K091547   Ketone, blood General Chemistry 03/02/2010
Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System  
K080960   Ketone, blood General Chemistry 10/17/2008
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM  
K040814   Ketone, blood General Chemistry 04/15/2004
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS KETONE TEST STRIPS  
K983860   Ketone, blood General Chemistry 05/10/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS KETONE TEST STRIPS  
K981865   Ketone, blood General Chemistry 05/10/2002
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM  
K983504   Ketone, blood General Chemistry 02/25/2000

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