510(k) Report

Devices descending from K992918

14 later devices reach STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation20126—
+1K110446Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral Fluid Dat…Roche Diagnostics20111—
+1K063024Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral…Lin-Zhi International, Inc.20061—
+1K033743Cozart Eia Amphetamines Oral Fluid Microplate KitCozart Bioscience, Ltd.20042—
+2K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc.20183—
+2K141748Rapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator…Biophor Diagnostics, Inc.20150—
+2K131653Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc.20140—
+2K132688Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZBiochemical Diagnostics, Inc.20131—
+2K130811Psychemedics Microplate Eia for AmphetaminePsychemedics Corp.20131—
+3K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd.20250—
+3K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation20210—
+3K181305OralTox Oral fluid Drug TestPremier Biotech, Inc.20181—
+3K133047Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…Biophor Diagnostics, Inc.20140—
+4K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC20260—