510(k) Report

Devices descending from K091361

5 later devices reach Immulite 2000 Syphilis Screen Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160910Elecsys SyphilisRoche Diagnostics20162—
+1K112343Treponema Pallidum Treponemal Test Reagents; Quality Control MaterialsSiemens Healthcare Diagnostics, Inc.201212
+2K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics20240—
+2K211302Elecsys SyphilisRoche Diagnostics20211—
+2K153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc.20160—