510(k) Report

Devices descending from K960187

7 later devices reach Cocaine Metabolite Eia Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181499DRI Cocaine Metabolite AssayMicrogenics Corporation20181—
+1K020763Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit)Lin-Zhi International, Inc.20024—
+2K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM)…Carolina Liquid Chemistries Corp.20220—
+2K211973DRI Cocaine Metabolite AssayMicrogenics Corporation20210—
+2K113139Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,ControlsLin-Zhi International, Inc.20111—
+2K033866Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits)Lin-Zhi International, Inc.20040—
+3K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX20200—