510(k) Report

Devices descending from K173183

2 later devices reach CEDIA Heroin Metabolite (6-AM) Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192943CEDIA Heroin Metabolite (6-AM) assayMicrogenics Corporation20191—
+2K231007CEDIA Heroin Metabolite (6-AM) AssayMicrogenics Corporation20230—