Cleared Traditional

DART PHENOBARBITAL ASSAY SYSTEM

K864612 · Coulter Electronics, Inc. · Toxicology
Jan 1987
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K864612 is an FDA 510(k) clearance for the DART PHENOBARBITAL ASSAY SYSTEM, a Nephelometric Inhibition Immunoassay, Phenobarbital (Class II — Special Controls, product code LFN), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on January 13, 1987, 50 days after receiving the submission on November 24, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K864612 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1986
Decision Date January 13, 1987
Days to Decision 50 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

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