510(k) Report

Devices descending from K901212

4 later devices reach Lig/TDM a, B, C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030452Bayer Ligand Plus 1, 2, 3 ControlsBayer Diagnostics Corp.20033—
+2K082141Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10Biokit, S.A.20080—
+2K060359Archiect Insulin and Controls, Model 8K41-01, 8K41-10Denka Seiken Co., Ltd.20061—
+3K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics20170—