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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
 
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Document Analyte Analyte Specialty Effective Date
Bayer A1C Now SelfCheck  
K090413 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 05/30/2012
Bayer A1CNow + Professional Use  
K051321 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
PROVALIS DIAGNOSTICS IN2IT IN-OFFICE ANALYZER (II) A1C PRESCRIPTION HOME USE TEST SYSTEM  
K041635 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 11/09/2004
PROVALIS DIAGNOSTICS G5 II HBA1C TEST SYSTEM  
K041635 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 08/18/2004
BIO-RAD MICROMAT II HEMOGLOBIN A1C PRESCRIPTION HOME USE TEST  
K021935 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 12/17/2002
Metrika A1cNow For Home Use  
K022661 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 11/19/2002

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