510(k) Report

Devices descending from K212778

1 later device reach Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No.… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243489Alinity m EBV (09N43-095)Abbott Molecular, Inc.20250—