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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 10 of 20 Results
Document Number K160282
 
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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
SD Biosensor USA, Inc., SD LipidoCare Professional System  {SD LipidoCare Professional Blood Glucose Test Strip} 
CR160041 K160282 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 10/23/2017
SD Biosensor USA, Inc., SD LipidoCare Professional System  {SD LipidoCare Professional Lipid Panel Test Strip} 
CR160041 K160282 Triglyceride General Chemistry WAIVED 10/23/2017
SD Biosensor USA, Inc., SD LipidoCare Professional System  {SD LipidoCare Professional Lipid Panel Test Strip} 
CR160041 K160282 HDL cholesterol General Chemistry WAIVED 10/23/2017
SD Biosensor USA, Inc., SD LipidoCare Professional System  {SD LipidoCare Professional Lipid Panel Test Strip} 
CR160041 K160282 Cholesterol General Chemistry WAIVED 10/23/2017
SD Biosensor USA, Inc., SD LipidoCare BT Professional System  {SD LipidoCare BT Professional Blood Glucose Test Strip} 
CR160041 K160282 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 10/23/2017
SD Biosensor USA, Inc., SD LipidoCare BT Professional System  {SD LipidoCare BT Professional Lipid Panel Test Strip} 
CR160041 K160282 Triglyceride General Chemistry WAIVED 10/23/2017

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