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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte Cholesterol Complexity waived
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Document Analyte Analyte Specialty Effective Date
Polymer Technology Systems CardioChek PA Analyzer  {PTS PANELS CHOL+HDL Panel Test Strips} 
K071593 Cholesterol General Chemistry 10/15/2007
Polymer Technology Systems Cardiochek Brand Analyzer  {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} 
K071507 Cholesterol General Chemistry 09/21/2007
Polymer Technology Systems CardioChek PA Analyzer  {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} 
K071507 Cholesterol General Chemistry 09/21/2007
Cholestech LDX  {Lipid Profile - ALT (GPT)} (Whole Blood)
K922612 Cholesterol General Chemistry 05/16/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K023642 Cholesterol General Chemistry 01/22/2007
Arkray SPOTCHEM EZ Chemistry Analyzer  {Lipid Panel} (Whole Blood)
K042443 Cholesterol General Chemistry 12/12/2006
Polymer Technology Systems CardioChek Analyzer  {PTS PANELS CHOL+HDL Test Panel Test Strips} 
K023558 Cholesterol General Chemistry 09/27/2005
Polymer Technology Systems CardioChek PA Analyzer  {PTS PANELS CHOL+HDL Test Panel Test Strips} 
K023558 Cholesterol General Chemistry 09/27/2005
Roche Diagnostics AccuChek Instant Plus Dual Testing System  
K051376 Cholesterol General Chemistry 08/24/2005
BIOMEDIX INC. Q STEPS Biometer G/C Dual Monitoring System  
K050182 Cholesterol General Chemistry 08/11/2005

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