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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number K230625
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Document Parent Analyte Analyte Specialty Complexity Effective Date
i-SENS U.S.A, Inc., ReliOn Premier BLU Blood Glucose Monitoring System  
CR230119 K230625 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 08/23/2023

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