510(k) K100433

IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, by Siemens Healthcare Diagnostics — Product Code LKQ

K100433 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,". The FDA issued a decision of Substantially Equivalent on May 13, 2010. The device falls under product code LKQ (Antibody Igm,If, Cytomegalovirus Virus), a Class II device regulated under 21 CFR 866.3175. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.