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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number K032279
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Roche Diagnostics, cobas pro integrated solutions, cobas c 703  {ONLINE TDM Amikacin} 
CR260306 K032279 Amikacin Toxicology / TDM MODERATE 05/06/2026
Roche Diagnostics, cobas c 303  {ONLINE TDM Amikacin} 
CR220440 k032279 Amikacin Toxicology / TDM MODERATE 12/05/2022
Roche Diagnostics cobas c 503 analytical unit  
CR200029 K032279 Amikacin Toxicology / TDM MODERATE 02/19/2020
Roche Diagnostics cobas c 502 Analyzer  
K100853 K032279 Amikacin Toxicology / TDM MODERATE 01/10/2011
Roche Diagnostics cobas c 311 Analyzer  
K032279 K032279 Amikacin Toxicology / TDM MODERATE 08/08/2007
Roche Diagnostics cobas c501 Analyzer  
K032279 K032279 Amikacin Toxicology / TDM MODERATE 04/05/2007
Roche Diagnostics Hitachi 911 Analyzer  {ROCHE DIAGNOSTICS ONLINE TDM AMIKACIN ASSAY} 
K032279 K032279 Amikacin Toxicology / TDM MODERATE 10/10/2003
Roche Diagnostics Hitachi 912 Analyzer  {ROCHE DIAGNOSTICS ONLINE TDM AMIKACIN ASSAY} 
K032279 K032279 Amikacin Toxicology / TDM MODERATE 10/10/2003
Roche Diagnostics Hitachi 917 Analyzer  {ROCHE DIAGNOSTICS ONLINE TDM AMIKACIN ASSAY} 
K032279 K032279 Amikacin Toxicology / TDM MODERATE 10/10/2003
Roche Diagnostics Hitachi Modular P  {ROCHE DIAGNOSTICS ONLINE TDM AMIKACIN ASSAY} 
K032279 K032279 Amikacin Toxicology / TDM MODERATE 10/10/2003

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