510(k) Report

Devices descending from K912024

9 later devices reach Automated Biochemical Analyzer (WAK0-20R & 30R) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970986Wako Direct Bilirubin VWako Chemicals USA, Inc.19974—
+1K970985Wako Total Bilirubin VWako Chemicals USA, Inc.19973—
+2K053131Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191Wako Chemicals USA, Inc.200501
+2K053132Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791Wako Chemicals USA, Inc.200522
+2K981943DBILAbbott Laboratories19980—
+2K981276N-Assay L D-BilCrestat Diagnostics, Inc.19980—
+2K981289N-Assay L T-BilCrestat Diagnostics, Inc.19980—
+3K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.20230—
+3K152343Direct BilirubinRandox Laboratories Limited20160—