Cleared Traditional

PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY

K011185 · Psychemedics Corp. · Toxicology
Jan 2002
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K011185 is an FDA 510(k) clearance for the PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY, a Thin Layer Chromatography, Methamphetamine (Class II — Special Controls, product code DJC), submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on January 24, 2002, 281 days after receiving the submission on April 18, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K011185 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2001
Decision Date January 24, 2002
Days to Decision 281 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJC — Thin Layer Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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