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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Document Number CR230775
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Document Parent Analyte Analyte Specialty Complexity Effective Date
GL Diabetes Corporation, SugarScan Enhance Blood Glucose Monitoring System  
CR230775 K182428 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 12/19/2023

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