Cleared Traditional

REVISED LABELING FOR METHAQUALONE TEST KIT

K874272 · Roche Diagnostic Systems, Inc. · Toxicology
Nov 1987
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K874272 is an FDA 510(k) clearance for the REVISED LABELING FOR METHAQUALONE TEST KIT, a Radioimmunoassay, Methaqualone (Class II — Special Controls, product code KXS), submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on November 13, 1987, 24 days after receiving the submission on October 20, 1987. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3630.

Submission Details

510(k) Number K874272 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1987
Decision Date November 13, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

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
METHAQUALONE ENZYME IMMUNOASSAY
K940123 · Diagnostic Reagents, Inc. · May 1994
SYVA EMIT II METHAQUALONE ASSAY
K921013 · Syva Co. · May 1992