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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 LIPID PANEL TEST STRIPS} 
K022898 Cholesterol General Chemistry 10/18/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS  
K981493 Cholesterol General Chemistry 06/25/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS  
K990688 Cholesterol General Chemistry 06/25/2002
LIFESTREAM TECHNOLOGIES PERSONAL CHOLESTEROL MONITOR  (For OTC use)
K000610 Cholesterol General Chemistry 07/19/2000
POLYMER TECHNOLOGY SYSTEMS, BIOSCANNER TEST STRIPS CHOLESTEROL  (For Professional Use)
K990247 Cholesterol General Chemistry 04/03/2000
POLYMER TECHNOLOGY SYSTEMS MTM BIOSCANNER 1000  (For Professional Use)
  Cholesterol General Chemistry 09/22/1999
POLYMER TECHNOLOGY SYSTEMS MTM BIOSCANNER 1000  (For OTC use)
K981493 Cholesterol General Chemistry 08/09/1999
Roche Diagnostics Accu-Chek InstantPlus Cholesterol  
K944458 Cholesterol General Chemistry 05/07/1999
Lifestream Technologies Cholesterol Monitor  
K981345 Cholesterol General Chemistry 02/24/1999
ActiMed Laboratories ENA.C.T Total Cholesterol Test (PDU)  
K981181 Cholesterol General Chemistry 12/02/1998

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