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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number K922914
 
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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 Valproic Acid Assay} 
CR250127 K922914 Procainamide Toxicology / TDM MODERATE 04/14/2025
Beckman Coulter, Inc., DxC 500 AU Clinical Chemistry Analyzer  {Siemens Syva Emit® 2000 Procainamide Assay} 
CR230612 K922914 Procainamide Toxicology / TDM MODERATE 10/30/2023
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  
CR180021 K922914 Procainamide Toxicology / TDM MODERATE 02/01/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  {Siemens Healthcare Diagnostics Inc. Emit 2000 Procainamide Assay} 
CR180021 K922914 Procainamide Toxicology / TDM MODERATE 02/01/2018
ELITECH Clinical Systems Selectra ProM  {Siemens EMIT 2000 Procainamide} 
CR150226 K922914 Procainamide Toxicology / TDM MODERATE 07/29/2015
Siemens Viva-ProE  
CR150008 K922914 Procainamide Toxicology / TDM MODERATE 02/05/2015
Beckman Coulter AU5800 Clinical Chemistry System  {Siemens Syva® Emit® 2000 Procainamide Assay} 
K011878 K922914 Procainamide Toxicology / TDM MODERATE 12/06/2012
Beckman Coulter AU640 Chemistry Analyzer  {Siemens Syva Emit 2000 Procainamide Assay} 
K922914 K922914 Procainamide Toxicology / TDM MODERATE 07/06/2012
Beckman Coulter AU680 Chemistry Analyzer  {Siemens Syva Emit 2000 Procainamide Assay} 
K922914 K922914 Procainamide Toxicology / TDM MODERATE 07/06/2012
Beckman Coulter AU480 Chemistry Analyzer  {Siemens Emit 2000 Procainamide Assay} 
K994005 K922914 Procainamide Toxicology / TDM MODERATE 06/04/2012

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