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CLIA - Clinical Laboratory Improvement Amendments

 
 
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Document Analyte Analyte Specialty Effective Date
Cardinal Health Leader Blood Glucose Monitoring System  
K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/13/2009
Arkray ReliOn Confirm Blood Glucose Monitoring System  
K073416 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/30/2009
Arkray, GLUCOCARD VITAL Blood Glucose Monitoring System  
K091102 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/30/2009
Fifty 50 Medical, Fifty 50 Glucose Monitoring System 2.0  
K083468 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/14/2009
Major Biosystem Corp. AP-1000 Blood Glucose Monitoring System  
K090389 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/14/2009
Fora Care Inc. FORA G90 Blood Glucose Monitoring System  
K091898 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/30/2009
Fora Care Inc. U-Right TD-4234 Blood Glucose Monitoring System  
K091898 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/30/2009
Fora Care Inc. U-Right TD-4250 Blood Glucose Monitoring System  
K083570 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/14/2009
Fora Care Inc. U-Right TD-4249 Blood Glucose Monitoring System  
K083570 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/14/2009
Bayer Contour USB Glucose Monitoring System  
K091820 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2009
 
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