510(k) Report

Devices descending from K053132

2 later devices reach Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.20230—
+1K152343Direct BilirubinRandox Laboratories Limited20160—