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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Prothrombin Time (PT) Complexity waived Effective Date To 04/25/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Hemosense INRatio Prothrombin Time (PT) Monitoring System  (Prescription Home Use)
K021923   Prothrombin time (PT) Hematology 05/29/2013
Coag-Sense Self-Test Prothrombin Time (PT/INR) Monitoring System  {Prescription Home Use} 
K093243   Prothrombin time (PT) Hematology 01/16/2013
Coag-Sense Prothrombin Time (PT/INR) Monitoring System  {Professional Use} 
K050243   Prothrombin time (PT) Hematology 01/16/2013
Roche Diagnostics CoaguChek XS Plus System  
K071041   Prothrombin time (PT) Hematology 09/18/2012
Alere INRatio┬«2 PT/INR Monitoring System (Professional Use)  (Professional Use)
K110212   Prothrombin time (PT) Hematology 05/08/2012
Alere INRatio┬«2 PT/INR Home Monitoring System  (Prescription Home Use)
K110212   Prothrombin time (PT) Hematology 05/08/2012
CoaguSense Prothrombin Time (PT)/INR Monitoring System  {Professional Use} 
K050243   Prothrombin time (PT) Hematology 09/20/2011
Alere, INRatio 2 PT/INR Monitoring System  (Professional Use)
K072727   Prothrombin time (PT) Hematology 06/22/2011
CoaguSense Self-Test Prothrombin Time/INR Monitoring System  {Prescription Home Use} 
K093243   Prothrombin time (PT) Hematology 04/15/2010
Roche Diagnostics CoaguChek XS Plus PST System  
K092940   Prothrombin time (PT) Hematology 03/09/2010

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