Cleared Traditional

MODEL 5500 CEAS

K963938 · Esa, Inc. · Chemistry
Dec 1996
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K963938 is an FDA 510(k) clearance for the MODEL 5500 CEAS, a Chromatographic/fluorometric Method, Catecholamines (Class I — General Controls, product code CHQ), submitted by Esa, Inc. (Chelmsford, US). The FDA issued a Cleared decision on December 26, 1996, 86 days after receiving the submission on October 1, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1165.

Submission Details

510(k) Number K963938 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1996
Decision Date December 26, 1996
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CHQ — Chromatographic/fluorometric Method, Catecholamines
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1165

Similar Devices — CHQ Chromatographic/fluorometric Method, Catecholamines

All 9
TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA
K051969 · Ibl GmbH · Oct 2005
ESA PLASMA FREE METANEPHRINE ANALYSIS KIT
K032199 · Esa, Inc. · Jan 2004
PLASMA CATECHOLAMINE KIT
K972167 · Bioanalytical Systems, Inc. · Aug 1997
URINARY METANEPHRINE KIT
K952919 · Bioanalytical Systems, Inc. · Sep 1995
URINARY CATECHOLAMINE KIT
K943099 · Bioanalytical Systems, Inc. · Oct 1994
MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM
K931148 · Esa, Inc. · Jun 1993