Neurochemical Analyzer

FDA 510(k) K864729 · Esa, Inc.

Substantially Equivalent

510(k) numberK864729

Submission

Device name
Neurochemical Analyzer
Applicant
Esa, Inc.
Bedford, MA, US
Received
December 4, 1986
Decision date
April 13, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LEQ – Detectors, Electrochemical, Liquid Chromatography
Device class
Class I (low risk)
Regulation
21 CFR 862.2260
Specialty
Clinical Chemistry

Other 510(k)s with product code LEQ

510(k)DeviceApplicantDecision
K962574Waters 474 Scanning Flourescence Detector (474)LEQ · Traditional Waters Corporation07/22/1996SE
K903231Coulochem IILEQ · Traditional Esa, Inc.09/27/1990SE
K801439Model 5100 Electrochemical DetectorLEQ · Traditional Environmental Sciences Assoc., Inc.07/21/1980SE

More from Environmental Sciences Assoc., Inc.

510(k)DeviceDecision
K032199Esa Plasma Free Metanephrine Analysis KitCHQ · Traditional 01/30/2004SE
K971640Leadcare Blood Lead Testing SystemDOF · Traditional 09/09/1997SE
K963938Model 5500 CeasCHQ · Traditional 12/26/1996SE
K934977Model 5500 CeasCDF · Traditional 01/11/1994SE
K931148Model 5500 Coulochem Electrode Array SystemCHQ · Traditional 06/09/1993SE
K903231Coulochem IILEQ · Traditional 09/27/1990SE

Questions and answers

When was Neurochemical Analyzer cleared by the FDA?

Neurochemical Analyzer (K864729) received a 510(k) decision of Substantially Equivalent on April 13, 1987, 130 days after the submission was received.

What is the product code of K864729?

The FDA product code is LEQ – Detectors, Electrochemical, Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.