510(k) Report

Devices descending from K936016

3 later devices reach Quantikine Ivd Erythropoietin Enzyme Linked Immunosorbent Assay (Elisa) 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