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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 24 Results
Document Number K962519
 
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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 Gentamicin Plus Assay} 
CR250127 K962519 Gentamicin Toxicology / TDM MODERATE 04/14/2025
Beckman Coulter, Inc., DxC 500 AU Clinical Chemistry Analyzer  {Siemens Syva Emit® 2000 Gentamicin Plus Assay} 
CR230612 K962519 Gentamicin Toxicology / TDM MODERATE 10/30/2023
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  
CR170670 K962519 Gentamicin Toxicology / TDM MODERATE 01/18/2018
Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer  {Siemens Healthcare Diagnostics Inc. Emit 2000 Gentamicin Plus Assay} 
CR170670 K962519 Gentamicin Toxicology / TDM MODERATE 01/18/2018
Siemens Healthcare Diagnostics ADVIA Chemistry XPT System  
CR160519 K962519 Gentamicin Toxicology / TDM MODERATE 10/24/2016
ELITECH Clinical Systems Selectra ProM  {Siemens EMIT 2000 Gentamicin Plus} 
CR150226 K962519 Gentamicin Toxicology / TDM MODERATE 07/29/2015
Siemens Viva-ProE  
CR150008 K962519 Gentamicin Toxicology / TDM MODERATE 02/05/2015
Beckman Coulter AU5800 Clinical Chemistry System  {Siemens Syva® Emit® 2000 GENTAMICIN PLUS ASSAY} 
K011878 K962519 Gentamicin Toxicology / TDM MODERATE 12/06/2012
Beckman Coulter Inc, AU640  {Siemens SYVA EMIT 2000 GENTAMICIN PLUS ASSAY} 
K962519 K962519 Gentamicin Toxicology / TDM MODERATE 09/14/2012
Beckman Coulter Inc, AU680  {Siemens SYVA EMIT 2000 GENTAMICIN PLUS ASSAY} 
K962519 K962519 Gentamicin Toxicology / TDM MODERATE 09/14/2012

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