Cleared Traditional

K212952 - Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair (FDA 510(k) Clearance)

K212952 · Psychemedics Corporation · Toxicology device

Apr 2022

Decision

214d

Days

Risk

K212952 is an FDA 510(k) clearance for the Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair. This device is classified as a Enzyme Immunoassay, Phencyclidine.

Submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on April 18, 2022, 214 days after receiving the submission on September 16, 2021.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number	K212952 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 16, 2021
Decision Date	April 18, 2022
Days to Decision	214 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF