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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 (FDA Cleared/Home Use) Complexity waived
 
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Document Analyte Analyte Specialty Effective Date
Progressive Health Supply and Source Corp., Smartest GlucoWise Blood Glucose Monitoring System Model 6267-S  
K122525 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/02/2013
Progressive Health Supply and Source Corp., Smartest GlucoWise MULTI Blood Glucose Monitoring System Model 6267-M  
K122525 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/02/2013
Nipro Diagnostics True Metrix Pro Professional Monitoring Blood Glucose System  
K120989 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/24/2013
Nipro Diagnostics True Metrix Self Monitoring Blood Glucose System  
K120989 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/24/2013
Medline EvenCare G2 Blood Glucose Monitoring System  
K113098 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/19/2013
Fora Care DIAVUE Prudential Blood Glucose Monitoring System  
K122307 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/16/2013
iHealth BG5 Wireless Smart Gluco-Monitoring System  
K123935 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/16/2013
iHealth BG5L Wireless Smart Gluco-Monitoring System  
K123935 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/16/2013
Nova Biomedical Nova Max Mini Glucose and B-Ketone Monitoring System  
K122688 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/16/2013
Philosys Gmate VOICE Blood Glucose Monitoring System  
K113636 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/15/2013

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