510(k) Report

Devices descending from K963695

3 later devices reach Immulite Anti-Tpo-AB (Lktoi,LKT05,Lktoz through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991096Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06Diagnostic Products Corp.19992—
+2K061382Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227Beckman Coulter, Inc.20061—
+3K240469Access TPO AntibodyBeckman Coulter, Inc.20240—