510(k) Report

Devices descending from K083222

1 later device reach Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112790Axis-Shield 3-Reagent Homocysteine Assay for SynchronAxis-Shield Diagnostics, Ltd.20120—