510(k) Report

Devices descending from K924446

21 later devices reach Micro-Plate Opiates Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981341STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc.199820—
+2K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation20126—
+2K101754Thermo Scientific Cedia Opiate Oft AssayMicrogenics Corp.20113—
+2K050988Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and ControlsLin-Zhi International, Inc.20066—
+2K030234Cozart Eia Cocaine Oral Fliud KitCozart Bioscience, Ltd.20030—
+2K020371Uplink Test SystemOraSure Technologies, Inc.20020—
+3K203564SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayImmunalysis Corporation20211—
+3K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc.20183—
+3K133642Rapidfret Oral Fluid Assay for Opiates; Rapidfret Oral Fluid Calibrators, Controls…Biophor Diagnostics, Inc.20140—
+3K132688Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZBiochemical Diagnostics, Inc.20131—
+3K063024Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral…Lin-Zhi International, Inc.20061—
+3K062242Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and ControlsLin-Zhi International, Inc.20063—
+4K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation20250—
+4K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd.20250—
+4K181305OralTox Oral fluid Drug TestPremier Biotech, Inc.20181—
+4K133047Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…Biophor Diagnostics, Inc.20140—
+4K131652Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc.20142—
+4K131653Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc.20140—
+5K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC20260—
+5K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation20210—
+5K142293Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…Biophor Diagnostics, Inc.20150—