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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Document Number K913429
 
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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 Phenytoin Assay} 
CR250127 K913429 Phenytoin Toxicology / TDM MODERATE 04/14/2025
Beckman Coulter, Inc., DxC 500 AU Clinical Chemistry Analyzer  {Siemens Syva Emit® 2000 Phenytoin Assay} 
CR230612 K913429 Phenytoin Toxicology / TDM MODERATE 10/30/2023
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  
CR170670 K913429 Phenytoin Toxicology / TDM MODERATE 01/18/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  {Siemens Healthcare Diagnostics Inc. Emit 2000 Phenytoin Assay} 
CR170670 K913429 Phenytoin Toxicology / TDM MODERATE 01/18/2018
Siemens Healthcare Diagnostics ADVIA Chemistry XPT System  
CR160519 K913429 Phenytoin Toxicology / TDM MODERATE 10/24/2016
Siemens Viva-ProE  
CR150008 K913429 Phenytoin Toxicology / TDM MODERATE 02/05/2015
Beckman Coulter Inc, AU680  {Siemens Syva Emit 2000 Phenytoin Assay} 
K913429 K913429 Phenytoin Toxicology / TDM MODERATE 10/05/2012
Beckman Coulter Inc, AU5400  {Siemens Syva Emit 2000 Phenytoin Assay} 
K913429 K913429 Phenytoin Toxicology / TDM MODERATE 10/05/2012
Beckman Coulter Inc, AU640  {Siemens Syva Emit 2000 Phenytoin Assay} 
K913429 K913429 Phenytoin Toxicology / TDM MODERATE 10/05/2012
Siemens Advia 1650 Chemistry System  
K913429 K913429 Phenytoin Toxicology / TDM MODERATE 03/24/2011

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