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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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11 to 20 of 49 Results
Analyte Hemoglobin Complexity waived Effective Date To 12/22/2014
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Document Parent Analyte Analyte Specialty Effective Date
Bayer A1CNow + Professional Use  
K090413   Glycosylated Hemoglobin (Hgb A1c) General Chemistry 05/30/2012
Diaspect Hemoglobin Measuring System  
BK110036   Hemoglobin Hematology 04/05/2012
Alere HemoPoint H2 Hemoglobin Measurement System  
K081719   Hemoglobin Hematology 10/05/2011
Stanbio HemoPoint H2 DM Hemoglobin Measurement System  {with Data Management} 
K090093   Hemoglobin Hematology 06/12/2009
MEC Dynamics Avie A1c Test System  
K081269   Glycosylated Hemoglobin (Hgb A1c) General Chemistry 04/01/2009
Siemens DCA 2000 analyzer  
K951361   Glycated hemoglobin, total General Chemistry 11/13/2008
Siemens DCA 2000+ analyzer  
K951361   Glycated hemoglobin, total General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110   Hemoglobin Hematology 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110   Hemoglobin Hematology 11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous Whole blood)
K053110   Hemoglobin Hematology 11/13/2008

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