Cleared Traditional

PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE

K130811 · Psychemedics Corp. · Toxicology
May 2013
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K130811 is an FDA 510(k) clearance for the PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on May 2, 2013, 38 days after receiving the submission on March 25, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K130811 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2013
Decision Date May 02, 2013
Days to Decision 38 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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