Cleared Traditional

COULOCHEM II

K903231 · Esa, Inc. · Toxicology

Sep 1990

Decision

66d

Days

Class 1

Risk

About This 510(k) Submission

K903231 is an FDA 510(k) clearance for the COULOCHEM II, a Detectors, Electrochemical, Liquid Chromatography (Class I — General Controls, product code LEQ), submitted by Esa, Inc. (Bedford, US). The FDA issued a Cleared decision on September 27, 1990, 66 days after receiving the submission on July 23, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number	K903231 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 1990
Decision Date	September 27, 1990
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—