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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Document Number CR210261
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Apex Biotechnology Corp., GlucoSure Link Blood Glucose Monitoring System  
CR210261 K212140 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 08/26/2022

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