510(k) Report

Devices descending from K991096

2 later devices reach Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061382Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227Beckman Coulter, Inc.20061—
+2K240469Access TPO AntibodyBeckman Coulter, Inc.20240—