510(k) Report

Devices descending from K011689

3 later devices reach Homogeneous Enzymic Homocysteine Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062808Liquid Stable (LS) 2-Part Homocysteine ReagentCatch Incorporated20062—
+2K083222Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100Axis-Shield Diagnostics, Ltd.200915
+3K112790Axis-Shield 3-Reagent Homocysteine Assay for SynchronAxis-Shield Diagnostics, Ltd.20120—