Cleared Traditional

PSYCHEMEDICS RIA CANNABINOID ASSAY

K011426 · Psychemedics Corp. · Toxicology
May 2002
Decision
360d
Days
Class 2
Risk

About This 510(k) Submission

K011426 is an FDA 510(k) clearance for the PSYCHEMEDICS RIA CANNABINOID ASSAY, a Radioimmunoassay, Cannabinoid(s) (Class II — Special Controls, product code LAT), submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on May 3, 2002, 360 days after receiving the submission on May 8, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K011426 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2001
Decision Date May 03, 2002
Days to Decision 360 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LAT — Radioimmunoassay, Cannabinoid(s)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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