510(k) Report

Devices descending from K061382

1 later device reach Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240469Access TPO AntibodyBeckman Coulter, Inc.20240—