Cleared Traditional

IPA FOR DETECTION OF PHENOBARBITAL

K821543 · Electro-Nucleonics Laboratories, Inc. · Toxicology
Jun 1982
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K821543 is an FDA 510(k) clearance for the IPA FOR DETECTION OF PHENOBARBITAL, a Nephelometric Inhibition Immunoassay, Phenobarbital (Class II — Special Controls, product code LFN), submitted by Electro-Nucleonics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1982, 10 days after receiving the submission on May 24, 1982. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K821543 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1982
Decision Date June 03, 1982
Days to Decision 10 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