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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 8 of 8 Results
Document Number K132086
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Diathrive, Inc., Diathrive HEALTH Blood Glucose Monitoring System  
CR230211 K132086 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 05/24/2023
Foodhold USA LLC, CareOne Express Blood Glucose Monitoring System  
CR200417 K132086 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 06/02/2021
Diathrive, Diathrive Blood Glucose Monitoring System  
CR180426 K132086 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 07/18/2018
Innovus Pharmaceuticals, Inc. GlucoGorx Blood Glucose Monitoring System  
CR180184 K132086 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 04/05/2018
Hudson Scientific LLC, D Care Blood Glucose Monitoring System  
CR170404 K132086 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 08/29/2017
Cardinal Health, Leader LE1 Blood Glucose Monitoring System  
CR160628 K132086 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 11/22/2016
ACON Laboratories, Inc., On Call Extra Blood Glucose Monitoring System  
CR140306 K132086 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 09/25/2014
On Call Express Blood Glucose Monitoring System  
K132086 K132086 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 12/20/2013

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