Cleared Traditional

ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE

K913722 · Roche Diagnostic Systems, Inc. · Toxicology
Sep 1991
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K913722 is an FDA 510(k) clearance for the ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE, a Radioimmunoassay, Cocaine Metabolite (Class II — Special Controls, product code KLN), submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on September 10, 1991, 25 days after receiving the submission on August 16, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K913722 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1991
Decision Date September 10, 1991
Days to Decision 25 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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