510(k) Report

Devices descending from K020769

5 later devices reach Single Analyte Urine Drugs of Abuse Calibrators and Controls 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—
+1K113139Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,ControlsLin-Zhi International, Inc.20111—
+2K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX20200—
+2K141803Immunalysis Tramadol Urine Enzyme ImmunoassayImmunalysis Corporation20151—
+3K203527Immunalysis Tapentadol Urine HEIALmmunalysis Corporation20220—