Cleared Traditional

PSYCHEMEDICS OPIATES EIA

K111926 · Psychemedics Corp. · Toxicology
May 2012
Decision
300d
Days
Class 2
Risk

About This 510(k) Submission

K111926 is an FDA 510(k) clearance for the PSYCHEMEDICS OPIATES EIA, 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 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 862.3650.

Submission Details

510(k) Number K111926 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 DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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