Cleared Traditional

DUPONT PHENOBARBITAL CALIBRATOR

K860303 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Feb 1986
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K860303 is an FDA 510(k) clearance for the DUPONT PHENOBARBITAL CALIBRATOR, a Nephelometric Inhibition Immunoassay, Phenobarbital (Class II — Special Controls, product code LFN), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on February 28, 1986, 31 days after receiving the submission on January 28, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K860303 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 1986
Decision Date February 28, 1986
Days to Decision 31 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