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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number K201396
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Document Parent Analyte Analyte Specialty Complexity Effective Date
MHC Medical Products, LLC. Member’s Mark BluLink Blood Glucose Monitoring System  
CR230201 K201396 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 06/15/2023
MHC Medical Products, LLC. Finetest Lite Smart Blood Glucose Monitoring System  
CR210357 K201396 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 03/10/2022
MHC Medical Products, LLC. Easy Touch BluLink Blood Glucose Monitoring System  
CR200554 K201396 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 10/12/2021

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