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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 10 of 21 Results
Document Number K832798
 
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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 Primidone Assay} 
CR250127 K832798 Primidone Toxicology / TDM MODERATE 04/14/2025
Beckman Coulter, Inc., DxC 500 AU Clinical Chemistry Analyzer  {Siemens Syva Emit® Primidone} 
CR230612 K832798 Primidone Toxicology / TDM MODERATE 10/30/2023
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  {Siemens Healthcare Diagnostics Inc. Emit Primidone Assay} 
CR180021 K832798 Primidone Toxicology / TDM MODERATE 02/01/2018
ELITECH Clinical Systems Selectra ProM  {Siemens EMIT Primidone} 
CR150226 K832798 Primidone Toxicology / TDM MODERATE 07/29/2015
Siemens Viva-ProE  
CR150109 K832798 Primidone Toxicology / TDM MODERATE 04/10/2015
Beckman Coulter AU5800 Clinical Chemistry System  {Siemens Syva® Emit® Primidone Assay} 
K011878 K832798 Primidone Toxicology / TDM MODERATE 12/06/2012
Beckman Coulter AU480  {Siemens Syva Emit Primidone Assay} 
K994005 K832798 Primidone Toxicology / TDM MODERATE 06/04/2012
Siemens Advia 1650 Chemistry System  
K832798 K832798 Primidone Toxicology / TDM MODERATE 03/24/2011
Beckman Coulter AU2700 Chemistry Analyzer  {Siemens Syva Emit Primidone Assay} 
K832798 K832798 Primidone Toxicology / TDM MODERATE 03/24/2011
Beckman Coulter AU400 Chemistry Analyzer  {Siemens Syva Emit Primidone Assay} 
K832798 K832798 Primidone Toxicology / TDM MODERATE 03/24/2011

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