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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 12 Results
Analyte Hematocrit Complexity waived Effective Date To 11/29/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Abbott i-STAT 6+ 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 E3+ 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
Vulcon Technologies Microspin 24  
K953519   Spun microhematocrit Hematology 11/09/1995
StatSpin Technologies CritSpin  
    Spun microhematocrit Hematology 06/02/1995
Separation Technology STI HemataSTAT Model C70  
K890849   Spun microhematocrit Hematology 09/01/1994

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