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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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31 to 40 of 500 Results *
Analyte Name Glucose monitoring devices (FDA cleared/home use) Clia Complexity waived
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Trividia Health, Inc. TRUENESS™ AIR Blood Glucose Monitoring System  
CR230278 K231476 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 12/04/2023
Trividia Health, Inc. TRUENESS™ Blood Glucose Monitoring System  
CR230278 K231476 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 12/04/2023
Greater Goods, LLC., Greater Goods M Blood Glucose Monitoring System  
CR230572 K223722 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 11/03/2023
Metene Limited, LPOW Blood Glucose Monitoring System  
CR230456 K182428 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 09/11/2023
i-SENS U.S.A, Inc., ReliOn Premier BLU Blood Glucose Monitoring System  
CR230119 K230625 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 08/23/2023
Roche Diabetes Care GmbH, Accu-Chek Guide Solo diabetes manager Glucose Monitoring System  
CR210419 K213131 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 08/17/2023
Medline Industries, LP, EvenCare G2 with Bluetooth Blood Glucose Monitoring System  
CR230275 K212140 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 06/30/2023
Mio Labs Inc. MIO Blood Glucose Monitoring System  
CR220497 K223722 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 06/29/2023
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
Diathrive, Inc., Diathrive HEALTH Blood Glucose Monitoring System  
CR230211 K132086 Glucose monitoring devices (FDA cleared/home use) General Chemistry WAIVED 05/24/2023

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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