Cleared Traditional

PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY

K011275 · Psychemedics Corp. · Toxicology
Feb 2002
Decision
291d
Days
—
Risk

About This 510(k) Submission

K011275 is an FDA 510(k) clearance for the PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY, a Radioimmunoassay, Phencyclidine, submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on February 11, 2002, 291 days after receiving the submission on April 26, 2001. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K011275 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2001
Decision Date February 11, 2002
Days to Decision 291 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCL — Radioimmunoassay, Phencyclidine
Device Class —

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