510(k) K142895

LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators by Fujirebio Diagnostics,Inc. — Product Code LTK

K142895 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators". The FDA issued a decision of Substantially Equivalent on May 21, 2015. The device falls under product code LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)), a Class II device regulated under 21 CFR 866.6010. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.