Cleared Traditional

MODEL 5100 ELECTROCHEMICAL DETECTOR

K801439 · Environmental Sciences Assoc., Inc. · Toxicology
Jul 1980
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K801439 is an FDA 510(k) clearance for the MODEL 5100 ELECTROCHEMICAL DETECTOR, a Detectors, Electrochemical, Liquid Chromatography (Class I — General Controls, product code LEQ), submitted by Environmental Sciences Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980, 31 days after receiving the submission on June 20, 1980. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K801439 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1980
Decision Date July 21, 1980
Days to Decision 31 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LEQ — Detectors, Electrochemical, Liquid Chromatography
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2260