Cleared Special

MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229

K011164 · Syva Co., Dade Behring, Inc. · Toxicology
May 2001
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K011164 is an FDA 510(k) clearance for the MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229, a Radioimmunoassay, Methaqualone (Class II — Special Controls, product code KXS), submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on May 10, 2001, 24 days after receiving the submission on April 16, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3630.

Submission Details

510(k) Number K011164 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2001
Decision Date May 10, 2001
Days to Decision 24 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

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

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