510(k) Report

Devices descending from K954687

2 later devices reach Access Rubella Igg through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250588Access Rubella IgGBeckman Coulter, Inc.20250—
+1K031606Access Immunoassay System Rubella Igg AssayBeckman Coulter, Inc.20030—