510(k) K072794

IMMULITE 2500 OM-MA, MODEL L5KOP by Siemens Medical Solutions Diagnostics — Product Code LTK

K072794 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions Diagnostics for the device "IMMULITE 2500 OM-MA, MODEL L5KOP". The FDA issued a decision of Substantially Equivalent on November 5, 2007. The device falls under product code LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)), a Class II device regulated under 21 CFR 866.6010. Siemens Medical Solutions Diagnostics has at least 10 other 510(k) clearances on record.