510(k) Report

Devices descending from K983715

4 later devices reach The Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020828CA 125 Assay for the Advia Centaur SystemBayer Corp.200232
+2K200199ADVIA Centaur CA 125IISiemens Healthcare Diagnostics, Inc.20200—
+2K142895LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA…Fujirebio Diagnostics,Inc.20150—
+2K100321Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal…Siemens Healthcare Diagnostics20110—