510(k) Report

Devices descending from K951495

3 later devices reach Access Toxo Igg Assay on the Access Immunoassay System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080869Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QCBeckman Coulter, Inc.20081—
+1K032162Access Immunoassay System Toxo Igg AssayBeckman Coulter, Inc.20032—
+2K242022Access Toxo IgGBeckman Coulter, Inc.20250—