510(k) Report

Devices descending from K120761

2 later devices reach Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141803Immunalysis Tramadol Urine Enzyme ImmunoassayImmunalysis Corporation20151—
+2K203527Immunalysis Tapentadol Urine HEIALmmunalysis Corporation20220—