510(k) Report

Devices descending from K100910

2 later devices reach Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112523Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics, Inc.20121—
+2K132801Immulite 2000 Systems 3GALLERGY Specific Ige AssaySiemens Healthcare Diagnostics, Inc.20140—