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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Hemoglobin Complexity waived
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Document Analyte Analyte Specialty Effective Date
BIOSAFE LABORTORIES, INC., ANEMIAPRO SELF SCREENER  
K042379 Hemoglobin Hematology 12/22/2004
HEMOCUE HB 201 DM ANALYZING SYSTEM  
K041234 Hemoglobin Hematology 06/28/2004
Stanbio HemoPoint H2 Hemoglobin Measurement System  
K032482 Hemoglobin Hematology 06/09/2004
EKF DIAGNOSTIC HEMO_CONTROL MEASUREMENT AND HEMO_CONTROL MICROCUVETTES  
K031898 Hemoglobin Hematology 11/03/2003

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