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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte HGB, single analyte inst. w/self-cont. Complexity waived Effective Date To 10/31/2014
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Document Parent Analyte Analyte Specialty Effective Date
HEMOCUE HB 201+SYSTEM  (CAPILLARY, VENOUS, ARTERIAL WHOLE BLOOD)
K032203   HGB, single analyte inst. w/self-cont. Hematology 06/30/2004
HEMOCUE HEMOGLOBIN 201 + / HEMOCUE HEMOGLOBIN MICROCUVETTE SYSTEM  
K032203   HGB, single analyte inst. w/self-cont. Hematology 05/04/2004
HEMOCUE DONOR HEMOGLOBIN CHECKER SYSTEM  
BK030020   HGB, single analyte inst. w/self-cont. Hematology 05/14/2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM  
K023561   HGB, single analyte inst. w/self-cont. Hematology 02/12/2003
BIOTEST HEMOGLOBIN MEASURING SYSTEM  
K020710   HGB, single analyte inst. w/self-cont. Hematology 08/29/2002
GDS TECHNOLOGY STAT-SITE M HGB TEST SYSTEM  
K020138   HGB, single analyte inst. w/self-cont. Hematology 02/11/2002
GDS Diagnostics HemoSite Meter  
K973649   HGB, single analyte inst. w/self-cont. Hematology 10/30/1998
HemoCue Hemoglobin System  
    HGB, single analyte inst. w/self-cont. Hematology 07/26/1993

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