510(k) Report

Devices descending from K970986

4 later devices reach Wako Direct Bilirubin V through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053132Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791Wako Chemicals USA, Inc.200522
+1K981276N-Assay L D-BilCrestat Diagnostics, Inc.19980—
+2K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.20230—
+2K152343Direct BilirubinRandox Laboratories Limited20160—