Cleared Traditional

STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541

K000399 · OraSure Technologies, Inc. · Toxicology
May 2000
Decision
98d
Days
—
Risk

About This 510(k) Submission

K000399 is an FDA 510(k) clearance for the STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541, a Enzyme Immunoassay, Phencyclidine, submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on May 15, 2000, 98 days after receiving the submission on February 7, 2000. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K000399 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2000
Decision Date May 15, 2000
Days to Decision 98 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

Similar Devices — LCM Enzyme Immunoassay, Phencyclidine

All 87
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
K212952 · Psychemedics Corporation · Apr 2022
SEFRIA PCP Oral Fluid Enzyme Immunoassay
K203489 · Immunalysis Corporation · Apr 2021
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
K181135 · Immunalysis Corporation · Jan 2019
Atellica CH Phencyclidine (Pcp)
K163220 · Siemens Healthcare Diagnostics, Inc. · Apr 2017
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K152176 · Immunalysis Corporation · Sep 2015
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
K142044 · Guangzhou Wondfo Biotech Co., Ltd. · Aug 2014