510(k) Report

Devices descending from K030452

3 later devices reach Bayer Ligand Plus 1, 2, 3 Controls through their predicates, nearest generation first.

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