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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 7 of 7 Results
Document Number K182428
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Document Parent Analyte Analyte Specialty Complexity Effective Date
GL Diabetes Corporation, SugarScan Enhance Blood Glucose Monitoring System  
CR230775 K182428 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 12/19/2023
Metene Limited, LPOW Blood Glucose Monitoring System  
CR230456 K182428 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 09/11/2023
Easy Healthcare Corporation, Easy@Home Blood Glucose Monitoring System  
CR230065 K182428 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 03/03/2023
Metene Limited, Metene Enhance Blood Glucose Monitoring System  
CR200386 K182428 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 09/14/2020
GL Diabetes Corporation, GL GoodLife 001 blood glucose monitoring system  
CR190580 K182428 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 10/15/2019
GL Diabetes Corp., FIA Biomed Precisa Blood Glucose Monitoring System  
CR190583 K182428 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 09/26/2019
GL Diabetes Corporation, GlucoLeader Enhance Blood Glucose Monitoring System  
CR180590 K182428 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 05/18/2019

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