510(k) Report

Devices descending from K960085

2 later devices reach Ise Calibrant a & B, Ise Liquid Reagent for Paramax Clinak Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060678Vitros Immunodiagnostic Products Anti-Hav Total Reagent Pack,Calibrator,ControlsOrtho-Clinical Diagnostics, Inc.20061—
+2K142758ADVIA Centaur HAV total assaySiemens Healthcare Diagnostics, Inc.20140—