510(k) Report

Devices descending from K984326

2 later devices reach Elecys Ige Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061970Elecsys Ige II ImmunoassayRoche Diagnostics20061—
+2K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.20220—