Cleared Traditional

QMS PHENOBARBITAL

K934388 · Seradyn, Inc. · Toxicology
Feb 1994
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K934388 is an FDA 510(k) clearance for the QMS PHENOBARBITAL, a Nephelometric Inhibition Immunoassay, Phenobarbital (Class II — Special Controls, product code LFN), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 25, 1994, 169 days after receiving the submission on September 9, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K934388 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1993
Decision Date February 25, 1994
Days to Decision 169 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LFN — Nephelometric Inhibition Immunoassay, Phenobarbital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3660