510(k) Report

Devices descending from K952559

4 later devices reach Erythropoietin Immunoassay Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980737Advantage Chemiluminescence Erythropoietin ImmunoassayNichols Institute Diagnostics19993—
+2K052223Access Epo AssayBeckman Coulter, Inc.200621
+3K240182Access EPOBeckman Coulter, Inc.20240—
+3K183088ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited201902