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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Glycosylated Hemoglobin (Hgb A1c) Complexity waived Effective Date To 10/26/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Alere Technologies AS, Alere Afinion AS100 Analyzer  
CR140337 K110056 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 09/23/2014
Chek Diagnostics A1C Now SelfCheck  
CR140168 K090413 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 07/28/2014
Chek Diagnostics A1C Now+ Professional Use  
CR140168 K090413 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 07/28/2014
BIO-RAD in2it (II) System Analyzer Prescription Home Use  
CR140092 K041635 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 05/22/2014
Bayer A1C Now SelfCheck  
K090413   Glycosylated Hemoglobin (Hgb A1c) General Chemistry 05/30/2012
Bayer A1CNow + Professional Use  
K090413   Glycosylated Hemoglobin (Hgb A1c) General Chemistry 05/30/2012
MEC Dynamics Avie A1c Test System  
K081269   Glycosylated Hemoglobin (Hgb A1c) General Chemistry 04/01/2009
Wako APOLOWAKO Analyzer  {Whole Blood} 
K080123   Glycosylated Hemoglobin (Hgb A1c) General Chemistry 10/31/2008
Siemens Medical Diagnostics DCA Vantage Analyzer  
K071466   Glycosylated Hemoglobin (Hgb A1c) General Chemistry 10/11/2007
Axis-Shield Afinion AS100 Analyzer  
K050574   Glycosylated Hemoglobin (Hgb A1c) General Chemistry 02/17/2006

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