Cleared Traditional

METHAQUALONE ENZYME IMMUNOASSAY

K940123 · Diagnostic Reagents, Inc. · Toxicology
May 1994
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K940123 is an FDA 510(k) clearance for the METHAQUALONE ENZYME IMMUNOASSAY, a Radioimmunoassay, Methaqualone (Class II — Special Controls, product code KXS), submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 3, 1994, 113 days after receiving the submission on January 10, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3630.

Submission Details

510(k) Number K940123 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 1994
Decision Date May 03, 1994
Days to Decision 113 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

Similar Devices — KXS Radioimmunoassay, Methaqualone

All 15
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
K011164 · Syva Co., Dade Behring, Inc. · May 2001
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
K993986 · Syva Co. · Jan 2000
SYNCHRON SYSTEMS METHAQUALONE REAGENT
K955676 · Beckman Instruments, Inc. · Mar 1996
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE
K945187 · Roche Diagnostic Systems, Inc. · Apr 1995
SYVA EMIT II METHAQUALONE ASSAY
K921013 · Syva Co. · May 1992
REVISED LABELING FOR METHAQUALONE TEST KIT
K874272 · Roche Diagnostic Systems, Inc. · Nov 1987