510(k) Report

Devices descending from K120763

5 later devices reach Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202007LZI Oxycodone III Enzyme ImmunoassayLin-Zhi International, Inc.20200—
+1K141055Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML)Lin-Zhi International, Inc.20143—
+2K150502DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone ControlsMicrogenics Corporation20152—
+3K231752ARK Hydrocodone AssayArk Diagnostics, Inc.20230—
+3K173195DRI Hydrocodone AssayMicrogenics Corporation20180—