510(k) Report

Devices descending from K063744

6 later devices reach Cobas Integra C 111 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122858Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…Elitechgroup20120—
+1K122083Elitech Clinical Systems CK Nac SLElitechgroup20121—
+1K110830Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…Elitechgroup201101
+1K071211Cobas C 111 AnalyzerRoche Diagnostics200713
+2K141265Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup20140—
+2K102647Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1…Elitechgroup Vital Scientific BV201104