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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Document Number K993981
 
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Siemens Healthcare Diagnostics Inc., Atellica DT 250 Analyzer  {Siemens Healthcare Diagnostics Inc., Syva Emit II Plus Propoxyphene Assay} 
CR250299 K993981 Propoxyphene Toxicology / TDM MODERATE 06/04/2025
Beckman Coulter, Inc., DxC 500i Clinical Analyzer  {Siemens Healthcare Diagnostics, Inc., Syva Emit II Plus Propoxyphene Assay} 
CR250127 K993981 Propoxyphene Toxicology / TDM MODERATE 04/14/2025
Siemens Healthcare Diagnostics Inc. Atellica CI Analyzer  {Atellica CH Propoxyphene (Ppx)} 
CR230646 K993981 Propoxyphene Toxicology / TDM MODERATE 10/31/2023
Beckman Coulter, Inc., DxC 500 AU Clinical Chemistry Analyzer  {Siemens Syva Emit® II Plus Propoxyphene Assay} 
CR230612 K993981 Propoxyphene Toxicology / TDM MODERATE 10/30/2023
Siemens Healthcare Diagnostics Inc. Atellica CH Analyzer  
CR190414 K993981 Propoxyphene Toxicology / TDM MODERATE 07/24/2019
Siemens Viva-ProE  
CR140294 K993981 Propoxyphene Toxicology / TDM MODERATE 05/14/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  
CR170670 K993981 Propoxyphene Toxicology / TDM MODERATE 01/18/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  {Siemens Healthcare Diagnostics Inc. Emit II Plus Propoxyphene Assay} 
CR170670 K993981 Propoxyphene Toxicology / TDM MODERATE 01/18/2018
Siemens Healthcare Diagnostics ADVIA Chemistry XPT System  
CR160519 K993981 Propoxyphene Toxicology / TDM MODERATE 10/24/2016
ELITECH Clinical Systems Selectra ProM  {Siemens EMIT II Plus Propoxyphene} 
CR150226 K993981 Propoxyphene Toxicology / TDM MODERATE 07/29/2015

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