510(k) Report

Devices descending from K050733

6 later devices reach Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120763Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone…Lin-Zhi International, Inc.20125—
+2K202007LZI Oxycodone III Enzyme ImmunoassayLin-Zhi International, Inc.20200—
+2K141055Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML)Lin-Zhi International, Inc.20143—
+3K150502DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone ControlsMicrogenics Corporation20152—
+4K231752ARK Hydrocodone AssayArk Diagnostics, Inc.20230—
+4K173195DRI Hydrocodone AssayMicrogenics Corporation20180—