510(k) Report

Devices descending from K983268

2 later devices reach Modification of Tricyclic Serum Tox Eia Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213875DRI TM Tricyclics Serum Tox AssayMicrogenics Corporation20221—
+2K231020Alinity c Tricyclic Antidepressants Reagent KitMicrogenics Corporation20230—