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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte Hematocrit Complexity waived
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Document Analyte Analyte Specialty Effective Date
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110 Hematocrit Hematology 11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous Whole blood)
K053110 Hematocrit Hematology 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110 Hematocrit Hematology 11/13/2008
Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood)
K053110 Hematocrit Hematology 09/21/2007
UltraCrit  
BK050056 Hematocrit Hematology 08/31/2006
Micro Diagnostics Spuncrit Model DRC-40 Infared Analyzer  
K961803 Hematocrit Hematology 02/23/1998
Wampole STAT-CRIT Hct  
  Hematocrit Hematology 03/04/1997

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