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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte Glucose Monitoring Devices (Prescription Use Only) Complexity waived
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Document Analyte Analyte Specialty Effective Date
Nova Biomedical Nova One Blood Glucose Monitoring System  
K122435 Glucose Monitoring Devices (Prescription Use Only) General Chemistry 12/20/2012
EPS BioTechnology Corporation; EASYMAX MU Pro Self-monitoring Blood Glucose System  
K121207 Glucose Monitoring Devices (Prescription Use Only) General Chemistry 05/22/2012
Gemco Medical EME Pro Self-Monitoring Blood Glucose System  
K112901 Glucose Monitoring Devices (Prescription Use Only) General Chemistry 01/04/2012
Nova Biomedical Corp. StatStrip Xpress Glucose Hosptial Meter  
K070960 Glucose Monitoring Devices (Prescription Use Only) General Chemistry 10/30/2009
Nova Biomedical Corp. StatStrip Glucose Hospital Meter  
K060345 Glucose Monitoring Devices (Prescription Use Only) General Chemistry 02/28/2008

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