510(k) Report

Devices descending from K970985

3 later devices reach Wako Total Bilirubin V through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053131Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191Wako Chemicals USA, Inc.200501
+1K981943DBILAbbott Laboratories19980—
+1K981289N-Assay L T-BilCrestat Diagnostics, Inc.19980—