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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 10 of 49 Results
Analyte Hemoglobin Complexity waived Effective Date To 12/22/2014
 
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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
AimStrip Hb Hemoglobin (Hb) Testing System  
K122553   Hemoglobin Hematology 03/21/2014
Clarity HbCheck Hemoglobin Testing System  
K122553   Hemoglobin Hematology 02/18/2014
Alere HemoPoint H2 System  
K081719   Hemoglobin Hematology 12/12/2013
Alere HemoPoint H2 Hemoglobin System  
K081719   Hemoglobin Hematology 08/22/2013
Avie Total Hb Test System  {Professional Use} 
K121752   Hemoglobin Hematology 01/07/2013
Bayer A1C Now SelfCheck  
K090413   Glycosylated Hemoglobin (Hgb A1c) General Chemistry 05/30/2012

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