510(k) Report

Devices descending from K013135

8 later devices reach Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2KUN6… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101572Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics201124
+1K091984Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics20090—
+1K091289Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20090—
+1K090257Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20090—
+1K083853Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20090—
+1K083314Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20090—
+2K112523Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics, Inc.20121—
+3K132801Immulite 2000 Systems 3GALLERGY Specific Ige AssaySiemens Healthcare Diagnostics, Inc.20140—