Cleared Traditional

ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE

K912756 · Roche Diagnostic Systems, Inc. · Toxicology
Jul 1991
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K912756 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY 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 July 26, 1991, 35 days after receiving the submission on June 21, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K912756 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 1991
Decision Date July 26, 1991
Days to Decision 35 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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