Cleared Traditional

PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR

K123799 · Psychemedics Corp. · Toxicology
Feb 2013
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K123799 is an FDA 510(k) clearance for the PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on February 8, 2013, 60 days after receiving the submission on December 10, 2012. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K123799 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2012
Decision Date February 08, 2013
Days to Decision 60 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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