510(k) Report

Devices descending from K011150

8 later devices reach Dridau Opiate Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143502Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300…Immunalysis Corporation20150—
+1K020368Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit)Lin-Zhi International, Inc.20026—
+2K120761Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate…Lin-Zhi International, Inc.20122—
+2K110298Opiate Enzyme ImmunoassayLin-Zhi International, Inc.20111—
+2K033866Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits)Lin-Zhi International, Inc.20040—
+3K172416Synermed Opiate Enzyme ImmunoassayInfrared Laboratory Systems, LLC (Dba Synermed)20180—
+3K141803Immunalysis Tramadol Urine Enzyme ImmunoassayImmunalysis Corporation20151—
+4K203527Immunalysis Tapentadol Urine HEIALmmunalysis Corporation20220—