510(k) Report

Devices descending from K031797

1 later device reach Methadone Metabolite (Eddp) Enzime Immunoassay, Cat. NO. 190 (500 Test Kit)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…Lin-Zhi International, Inc.20170—