510(k) Report

Devices descending from K063543

10 later devices reach Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131544Cobas C Bilirubin Total Gen.3Roche Diagnostics201312
+1K123965Cobas Integra Bilirubin Direct Gen.2Roche Diagnostics20130—
+1K063744Cobas Integra C 111Rochdiag20076—
+2K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.20260—
+2K122858Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…Elitechgroup20120—
+2K122083Elitech Clinical Systems CK Nac SLElitechgroup20121—
+2K110830Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…Elitechgroup201101
+2K071211Cobas C 111 AnalyzerRoche Diagnostics200713
+3K141265Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup20140—
+3K102647Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1…Elitechgroup Vital Scientific BV201104