510(k) Report

Devices descending from K002331

5 later devices reach Profile-ER through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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
+2K100023Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemMedtox Diagnostics, Inc.20100—
+3K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited20260—