510(k) K022329

CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM by Bayer Diagnostics Corp. — Product Code LTK

K022329 is an FDA 510(k) premarket notification submitted by Bayer Diagnostics Corp. for the device "CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 27, 2002. The device falls under product code LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)), a Class II device regulated under 21 CFR 866.6010. Bayer Diagnostics Corp. has at least 10 other 510(k) clearances on record.