Cleared Traditional

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair

K201228 · Psychemedics Corporation · Toxicology
Jun 2021
Decision
414d
Days
Class 2
Risk

About This 510(k) Submission

K201228 is an FDA 510(k) clearance for the Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair, a Enzyme Immunoassay, Cocaine (Class II — Special Controls, product code JXO), submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on June 25, 2021, 414 days after receiving the submission on May 7, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K201228 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2020
Decision Date June 25, 2021
Days to Decision 414 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

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