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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number K922913
 
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Beckman Coulter, Inc., DxC 500i Clinical Analyzer  {Siemens Healthcare Diagnostics, Inc., Syva Emit 2000 Quinidine Assay} 
CR250127 K922913 Quinidine Toxicology / TDM MODERATE 04/14/2025
Beckman Coulter, Inc., DxC 500 AU Clinical Chemistry Analyzer  {Siemens Syva Emit® 2000 Quinidine Assay} 
CR230612 K922913 Quinidine Toxicology / TDM MODERATE 10/30/2023
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  
CR180021 K922913 Quinidine Toxicology / TDM MODERATE 02/01/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  {Siemens Healthcare Diagnostics Inc. Emit 2000 Quinidine Assay} 
CR180021 K922913 Quinidine Toxicology / TDM MODERATE 02/01/2018
Siemens Viva-ProE  
CR150109 K922913 Quinidine Toxicology / TDM MODERATE 04/10/2015
Beckman Coulter AU5800 Clinical Chemistry System  {Siemens Syva® Emit® 2000 Quinidine Assay} 
K011878 K922913 Quinidine Toxicology / TDM MODERATE 12/06/2012
Beckman Coulter AU480  {Siemens Syva EMIT 2000 Quinidine Assay} 
K994005 K922913 Quinidine Toxicology / TDM MODERATE 06/04/2012
Beckman Coulter AU640 Chemistry Analyzer  {Siemens Syva EMIT 2000 Quinidine Assay} 
K922913 K922913 Quinidine Toxicology / TDM MODERATE 04/17/2012
Beckman Coulter Olympus AU680 Chemistry Analyzer  {Siemens Syva EMIT 2000 Quinidine Assay} 
K922913 K922913 Quinidine Toxicology / TDM MODERATE 04/17/2012
Bayer Advia 1650  {Siemens EMIT 2000 QUININDINE ASSAY} 
K922913 K922913 Quinidine Toxicology / TDM MODERATE 02/02/2011

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