510(k) Report

Devices descending from K001197

12 later devices reach Cocaine Metabolite Intercept Micro-Plate Eia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation20126—
+1K101742Thermo Scientific Cedia Cocaine Oft AssayMicrogenics Corp.20111—
+1K050945Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, Calibrators & ControlsLin-Zhi International, Inc.20062—
+2K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc.20183—
+2K142129Rapidfret Oral Fluid Assay for Cocaine, Rapidfret Oral Fluid Cocaine Calibrator Set…Biophor Diagnostics, Inc.20150—
+2K132688Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZBiochemical Diagnostics, Inc.20131—
+2K063024Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral…Lin-Zhi International, Inc.20061—
+3K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd.20250—
+3K181305OralTox Oral fluid Drug TestPremier Biotech, Inc.20181—
+3K133047Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…Biophor Diagnostics, Inc.20140—
+3K131653Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc.20140—
+4K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC20260—