510(k) Report

Devices descending from K014101

21 later devices reach Rapidone-Oxy Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123799Psychemedics Microplate Eia for Oxycodone in HairPsychemedics Corp.20131—
+1K103161Omega Laboratories Hair Drug Screening Assay for OpiatesOmega Laboratories, Inc.20111—
+1K040411Dri Oxycodone AssayMicrogenics Corp.200416—
+2K201326Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics…Psychemedics Corporation20210—
+2K172910Emit II Plus Oxycodone AssaySiemens Healthcare Diagnostics, Inc.20170—
+2K140671Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and HydrocodoneOmega Laboratories, Inc.20150—
+2K131168Immunalysis Oxycodone Enzyme ImmunoassayImmunalysis Corporation20140—
+2K060351Medtox OxycodoneMedtox Diagnostics, Inc.20066—
+2K050733Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and ControlsLin-Zhi International, Inc.20056—
+3K130650Status DS OxyPrinceton BioMeditech Corp.20140—
+3K120763Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone…Lin-Zhi International, Inc.20125—
+3K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc.20094—
+4K221550Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited20230—
+4K220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited202311
+4K202007LZI Oxycodone III Enzyme ImmunoassayLin-Zhi International, Inc.20200—
+4K141055Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML)Lin-Zhi International, Inc.20143—
+4K100023Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemMedtox Diagnostics, Inc.20100—
+5K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited20260—
+5K150502DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone ControlsMicrogenics Corporation20152—
+6K231752ARK Hydrocodone AssayArk Diagnostics, Inc.20230—
+6K173195DRI Hydrocodone AssayMicrogenics Corporation20180—