Cleared Traditional

NEUROCHEMICAL ANALYZER

K864729 · Esa, Inc. · Chemistry

Apr 1987

Decision

130d

Days

Class 1

Risk

About This 510(k) Submission

K864729 is an FDA 510(k) clearance for the NEUROCHEMICAL ANALYZER, 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 April 13, 1987, 130 days after receiving the submission on December 4, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number	K864729 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 1986
Decision Date	April 13, 1987
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—