Cleared Traditional

PSYCHEMEDICS RIA COCAINE ASSAY

K010868 · Psychemedics Corp. · Toxicology
Nov 2001
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K010868 is an FDA 510(k) clearance for the PSYCHEMEDICS RIA COCAINE ASSAY, a Radioimmunoassay, Cocaine Metabolite (Class II — Special Controls, product code KLN), submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on November 6, 2001, 228 days after receiving the submission on March 23, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K010868 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2001
Decision Date November 06, 2001
Days to Decision 228 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KLN — Radioimmunoassay, Cocaine Metabolite
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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