510(k) Report

Devices descending from K020828

3 later devices reach CA 125 Assay for the Advia Centaur System through their predicates, nearest generation first.

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