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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 9 of 9 Results
Document Number K030428
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Roche Diagnostics, cobas pro integrated solutions, cobas c 703  {ONLINE TDM Phenytoin} 
CR260306 K030428 Phenytoin Toxicology / TDM MODERATE 05/06/2026
Roche Diagnostics, cobas c 303  {ONLINE TDM Phenytoin} 
CR220440 k030428 Phenytoin Toxicology / TDM MODERATE 12/05/2022
Roche Diagnostics cobas c 503 analytical unit  
CR200029 K030428 Phenytoin Toxicology / TDM MODERATE 02/19/2020
Roche Diagnostics cobas c 502 Analyzer  
K100853 K030428 Phenytoin Toxicology / TDM MODERATE 01/10/2011
Roche Diagnostics cobas c 311 Analyzer  
K030428 K030428 Phenytoin Toxicology / TDM MODERATE 01/22/2008
Roche Diagnostics Hitachi 911  {ONLINE TDM PHENYTOIN} 
K030428 K030428 Phenytoin Toxicology / TDM MODERATE 01/20/2004
Roche Diagnostics Hitachi 912  {ONLINE TDM PHENYTOIN} 
K030428 K030428 Phenytoin Toxicology / TDM MODERATE 01/20/2004
Roche Diagnostics Hitachi 917  {ONLINE TDM PHENYTOIN} 
K030428 K030428 Phenytoin Toxicology / TDM MODERATE 01/20/2004
Roche Diagnostics Hitachi Modular P  {ONLINE TDM PHENYTOIN} 
K030428 K030428 Phenytoin Toxicology / TDM MODERATE 01/20/2004

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