Cleared Traditional

PSYCHEMEDICS COCAINE EIA

K111925 · Psychemedics Corp. · Toxicology
May 2012
Decision
300d
Days
Class 2
Risk

About This 510(k) Submission

K111925 is an FDA 510(k) clearance for the PSYCHEMEDICS COCAINE EIA, a Enzyme Immunoassay, Cocaine (Class II — Special Controls, product code JXO), submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on May 1, 2012, 300 days after receiving the submission on July 6, 2011. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K111925 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2011
Decision Date May 01, 2012
Days to Decision 300 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXO — Enzyme Immunoassay, Cocaine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

Similar Devices — JXO Enzyme Immunoassay, Cocaine

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
K201228 · Psychemedics Corporation · Jun 2021
AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY
K923314 · Serex, Inc. · Aug 1992
STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA
K921140 · Solarcare Technologies Corp,Inc. · Aug 1992
STC DIAGNOSTICS BENZOYLECGONINE EIA
K915785 · Solarcare Technologies Corp,Inc. · Mar 1992
IL TEST(TM) COCAINE
K913737 · Instrumentation Laboratory CO · Dec 1991