510(k) Report

Devices descending from K911511

13 later devices reach Alastat Allergen Specified Ige System, Modified through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013135Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2KUN6 (600 Tests)Diagnostic Products Corp.20018—
+1K013134Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600 Tests)Diagnostic Products Corp.2001102
+1K973186Immulite Cat-Specific Ige, Immulite Dog-Specific Ige,Immulite Mite-Specific IgeDiagnostic Products Corp.19970—
+2K260331IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)Siemens Healthcare Diagnostics Products, Ltd.20260—
+2K101572Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics201124
+2K093987Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6Siemens Healthcare Diagnostics, Inc.20112—
+2K091984Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics20090—
+2K091289Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20090—
+2K090257Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20090—
+2K083853Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20090—
+2K083314Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20090—
+3K112523Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics, Inc.20121—
+4K132801Immulite 2000 Systems 3GALLERGY Specific Ige AssaySiemens Healthcare Diagnostics, Inc.20140—