510(k) Report

Devices descending from K000399

12 later devices reach STC PCP Intercept Micro-Plate Eia, Model 11541 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation20126—
+1K101746Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayMicrogenics Corp.20113—
+1K093989Oral Fluid PhencyclidineRoche Diagnostics20110—
+2K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc.20183—
+2K132688Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZBiochemical Diagnostics, Inc.20131—
+2K122703Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease…Biophor Diagnostics, Inc.20132—
+3K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd.20250—
+3K181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation20191—
+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—
+4K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation20210—