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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 11 Results
Document Number K011347
 
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Document Parent Analyte Analyte Specialty Complexity Effective Date
ELITECH Clinical Systems Selectra ProM  {Siemens EMIT 2000 Phenytoin} 
CR150226 K011347 Phenytoin Toxicology / TDM MODERATE 07/29/2015
Beckman Coulter AU5800 Clinical Chemistry System  {Siemens Syva® Emit® 2000 Phenytoin Assay} 
K011878 K011347 Phenytoin Toxicology / TDM MODERATE 12/06/2012
Beckman Coulter AU480  {Siemens Syva Emit 2000 Phenytoin Assay} 
K994005 K011347 Phenytoin Toxicology / TDM MODERATE 06/04/2012
Beckman Coulter AU2700 Chemistry Analyzer  {Siemens Syva Emit 2000 Phenytoin Assay} 
K913429 K011347 Phenytoin Toxicology / TDM MODERATE 03/24/2011
Beckman Coulter AU400 Chemistry Analyzer  {Siemens Syva Emit 2000 Phenytoin Assay} 
K913429 K011347 Phenytoin Toxicology / TDM MODERATE 03/24/2011
Beckman Coulter AU600 Chemistry Analyzer  {Siemens Syva Emit 2000 Phenytoin Assay} 
K913429 K011347 Phenytoin Toxicology / TDM MODERATE 03/24/2011
Olympus AU 600  {SYVA EMIT 2000 PHENYTOIN ASSAY} 
K011347 K011347 Phenytoin Toxicology / TDM MODERATE 07/03/2001
OLYMPUS AU 800  {SYVA EMIT 2000 PHENYTOIN ASSAY} 
K011347 K011347 Phenytoin Toxicology / TDM MODERATE 07/03/2001
Olympus Au 2700  {SYVA EMIT 2000 PHENYTOIN ASSAY} 
K011347 K011347 Phenytoin Toxicology / TDM MODERATE 07/03/2001
Olympus AU 400  {SYVA EMIT 2000 PHENYTOIN ASSAY} 
K011347 K011347 Phenytoin Toxicology / TDM MODERATE 07/03/2001

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