510(k) Report

Devices descending from K040411

16 later devices reach Dri Oxycodone Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172910Emit II Plus Oxycodone AssaySiemens Healthcare Diagnostics, Inc.20170—
+1K131168Immunalysis Oxycodone Enzyme ImmunoassayImmunalysis Corporation20140—
+1K060351Medtox OxycodoneMedtox Diagnostics, Inc.20066—
+1K050733Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and ControlsLin-Zhi International, Inc.20056—
+2K130650Status DS OxyPrinceton BioMeditech Corp.20140—
+2K120763Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone…Lin-Zhi International, Inc.20125—
+2K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc.20094—
+3K221550Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited20230—
+3K220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited202311
+3K202007LZI Oxycodone III Enzyme ImmunoassayLin-Zhi International, Inc.20200—
+3K141055Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML)Lin-Zhi International, Inc.20143—
+3K100023Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemMedtox Diagnostics, Inc.20100—
+4K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited20260—
+4K150502DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone ControlsMicrogenics Corporation20152—
+5K231752ARK Hydrocodone AssayArk Diagnostics, Inc.20230—
+5K173195DRI Hydrocodone AssayMicrogenics Corporation20180—