510(k) Report

Devices descending from K000535

3 later devices reach Quanta Lite LKM-1 Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163538QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1…Inova Diagnostics, Inc.20170—
+1K113439Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)Euroimmun US20130—
+1K112223Euroimmun Anti-LKM-1 Elisa (LGG)Euroimmun US20120—