510(k) Report

Devices descending from K071971

2 later devices reach Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, and Calibrators, Model (S)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121053Diazyme Homocysteine Poc Test KitDiazyme Laboratories20120—
+1K113793Homocysteine TestRoche201203