510(k) Report

Devices descending from K020368

6 later devices reach Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021… through their predicates, nearest generation first.

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