510(k) Report

Devices descending from K954575

2 later devices reach Axsym Toxo Igg Antibody Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080869Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QCBeckman Coulter, Inc.20081—
+2K242022Access Toxo IgGBeckman Coulter, Inc.20250—