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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number K212140
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Medline Industries, LP, EvenCare G2 with Bluetooth Blood Glucose Monitoring System  
CR230275 K212140 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 06/30/2023
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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