510(k) Report

Devices descending from K171403

3 later devices reach OralTox Oral Fluid Drug Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd.20250—
+1K181305OralTox Oral fluid Drug TestPremier Biotech, Inc.20181—
+2K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC20260—