Cleared Traditional

ROCHE ABUSCREEN ONLINE FOR METHAQUALONE

K945187 · Roche Diagnostic Systems, Inc. · Toxicology
Apr 1995
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K945187 is an FDA 510(k) clearance for the ROCHE ABUSCREEN ONLINE FOR METHAQUALONE, a Radioimmunoassay, Methaqualone (Class II — Special Controls, product code KXS), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 5, 1995, 163 days after receiving the submission on October 24, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3630.

Submission Details

510(k) Number K945187 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 1994
Decision Date April 05, 1995
Days to Decision 163 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code KXS — Radioimmunoassay, Methaqualone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3630

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