Cleared Traditional

SYVA EMIT II METHAQUALONE ASSAY

K921013 · Syva Co. · Toxicology
May 1992
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K921013 is an FDA 510(k) clearance for the SYVA EMIT II METHAQUALONE ASSAY, a Radioimmunoassay, Methaqualone (Class II — Special Controls, product code KXS), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on May 13, 1992, 71 days after receiving the submission on March 3, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3630.

Submission Details

510(k) Number K921013 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1992
Decision Date May 13, 1992
Days to Decision 71 days
Submission Type Traditional
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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