510(k) Report

Devices descending from K080635

9 later devices reach Medtoxscan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140665GenPrime Snap-Top Split Key CupGenprime, Inc.20140—
+1K130082Genprime Drugs of Abuse Reader SystemGenprime, Inc.20132—
+1K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc.20094—
+2K221550Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited20230—
+2K220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited202311
+2K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.20191—
+2K100023Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemMedtox Diagnostics, Inc.20100—
+3K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited20260—
+3K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.20200—