Cleared Traditional

SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL

K993986 · Syva Co. · Toxicology
Jan 2000
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K993986 is an FDA 510(k) clearance for the SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL, a Radioimmunoassay, Methaqualone (Class II — Special Controls, product code KXS), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 27, 2000, 64 days after receiving the submission on November 24, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3630.

Submission Details

510(k) Number K993986 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1999
Decision Date January 27, 2000
Days to Decision 64 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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