510(k) Report

Devices descending from K031393

2 later devices reach Bayer Advia Centaur CA 19-9 Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253528Atellica IM CA 19-9 IISiemens Healthcare Diagnostics, Inc.20260—
+1K100375Dimension Vista Loci CA 19-9 Flex Reagent Cartridge, and Dimension LOCI7 Calibrator with…Siemens Healthcare Diagnostics, Inc.20110—