510(k) Report

Devices descending from K070709

2 later devices reach Roche Elecsys PTH Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231927Elecsys PTH , Elecsys PTH STATRoche Diagnostics20240—
+1K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical Diagnostics20230—