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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 result found
Document Number CR210419
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Roche Diabetes Care GmbH, Accu-Chek Guide Solo diabetes manager Glucose Monitoring System  
CR210419 K213131 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 08/17/2023

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