Cleared Traditional

PSYCHEMEDICS CANNABINOIDS EIA

K111929 · Psychemedics Corp. · Toxicology
May 2012
Decision
300d
Days
Class 2
Risk

About This 510(k) Submission

K111929 is an FDA 510(k) clearance for the PSYCHEMEDICS CANNABINOIDS EIA, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), 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 862.3870.

Submission Details

510(k) Number K111929 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 LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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