510(k) Report

Devices descending from K801118

3 later devices reach Cobas Reagent for Ast (Sgot) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060318Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx200621
+2K102647Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1…Elitechgroup Vital Scientific BV201104
+2K093883Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250…Seppim S.A.S.20100—