510(k) Report

Devices descending from K160910

2 later devices reach Elecsys Syphilis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics20240—
+1K211302Elecsys SyphilisRoche Diagnostics20211—