Cleared Traditional

URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)

K913867 · Immunalysis Corporation · Toxicology
Sep 1991
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K913867 is an FDA 510(k) clearance for the URINE COCAINE METABOLITE DIRECT RIA KIT (I-125), a Radioimmunoassay, Cocaine Metabolite (Class II — Special Controls, product code KLN), submitted by Immunalysis Corporation (Glendale, US). The FDA issued a Cleared decision on September 19, 1991, 23 days after receiving the submission on August 27, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K913867 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1991
Decision Date September 19, 1991
Days to Decision 23 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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