Cleared Traditional

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair

K210212 · Psychemedics Corporation · Toxicology
Dec 2021
Decision
322d
Days
Class 2
Risk

About This 510(k) Submission

K210212 is an FDA 510(k) clearance for the Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair, a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on December 15, 2021, 322 days after receiving the submission on January 27, 2021. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K210212 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2021
Decision Date December 15, 2021
Days to Decision 322 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LAF — Gas Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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