510(k) Report

Devices descending from K112343

1 later device reach Treponema Pallidum Treponemal Test Reagents; Quality Control Materials through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc.20160—