Cleared Traditional

Psychemedics Microplate EIA for Benzodiazepines in Hair

K163590 · Psychemedics Corporation · Toxicology
Sep 2017
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K163590 is an FDA 510(k) clearance for the Psychemedics Microplate EIA for Benzodiazepines in Hair, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on September 15, 2017, 269 days after receiving the submission on December 20, 2016. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K163590 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2016
Decision Date September 15, 2017
Days to Decision 269 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXM — Enzyme Immunoassay, Benzodiazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3170

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