FDA 510(k) Applications for Medical Device Product Code "LKQ"
(Antibody Igm,If, Cytomegalovirus Virus)

FDA 510(k) Number Applicant Device Name Decision Date
K972884 BOSTON BIOMEDICA, INC. ACCURUN 146 CMV IGM POSITIVE CONTROL 08/22/1997
K100433 SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, 05/13/2010


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