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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 4 of 4 Results
Document Number CR240617
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Document Parent Analyte Analyte Specialty Complexity Effective Date
The Sommet, Inc., CURO L7 System  {CURO L7 Lipid Test Strip - Lipid Profile} 
CR240617 K160282 Triglyceride General Chemistry WAIVED 02/05/2025
The Sommet, Inc., CURO L7 System  {CURO L7 Lipid Test Strip - Lipid Profile} 
CR240617 K160282 HDL cholesterol General Chemistry WAIVED 02/05/2025
The Sommet, Inc., CURO L7 System  {CURO L7 Lipid Test Strip - Lipid Profile} 
CR240617 K160282 Cholesterol General Chemistry WAIVED 02/05/2025
The Sommet, Inc., CURO L7 System  {CURO L7 Blood Glucose Test Strip} 
CR240617 K160282 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 02/05/2025

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