510(k) Report

Devices descending from K980737

3 later devices reach Advantage Chemiluminescence Erythropoietin Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052223Access Epo AssayBeckman Coulter, Inc.200621
+2K240182Access EPOBeckman Coulter, Inc.20240—
+2K183088ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited201902