510(k) Report

Devices descending from K103227

6 later devices reach Oratect Oral Fluid Drug Screen Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc.20183—
+1K132688Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZBiochemical Diagnostics, Inc.20131—
+2K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd.20250—
+2K181305OralTox Oral fluid Drug TestPremier Biotech, Inc.20181—
+2K133047Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…Biophor Diagnostics, Inc.20140—
+3K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC20260—