Urinary Catecholamine Kit

FDA 510(k) K943099 · Bioanalytical Systems, Inc.

Substantially Equivalent

510(k) numberK943099

Submission

Device name
Urinary Catecholamine Kit
Applicant
Bioanalytical Systems, Inc.
West Lafayette, IN, US
Received
June 29, 1994
Decision date
October 7, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CHQ – Chromatographic/Fluorometric Method, Catecholamines
Device class
Class I (low risk)
Regulation
21 CFR 862.1165
Specialty
Clinical Chemistry

Other 510(k)s with product code CHQ

510(k)DeviceApplicantDecision
K051969Tricat Ria (Adrenalin/Noradrenalin/Dopamine); Katcombi Ria (Adrenalin/Noradrenalin)…CHQ · Traditional Ibl GmbH10/03/2005SE
K032199Esa Plasma Free Metanephrine Analysis KitCHQ · Traditional Esa, Inc.01/30/2004SE
K972167Plasma Catecholamine KitCHQ · Traditional Bioanalytical Systems, Inc.08/04/1997SE
K963938Model 5500 CeasCHQ · Traditional Esa, Inc.12/26/1996SE
K952919Urinary Metanephrine KitCHQ · Traditional Bioanalytical Systems, Inc.09/06/1995SE
K931148Model 5500 Coulochem Electrode Array SystemCHQ · Traditional Esa, Inc.06/09/1993SE
K894966Plasma Catecholamines by HPLCCHQ · Traditional Bio-Rad10/25/1989SE
K873371Urinary Free Catecholamines & Metanephrines (HPLC)CHQ · Traditional Bio-Rad01/05/1988SE
K855214CAT-3 Catecholamine Assay KitCHQ · Traditional Whale Scientific, Inc.03/14/1986SE

More from Whale Scientific, Inc.

510(k)DeviceDecision
K972167Plasma Catecholamine KitCHQ · Traditional 08/04/1997SE
K952919Urinary Metanephrine KitCHQ · Traditional 09/06/1995SE

Questions and answers

When was Urinary Catecholamine Kit cleared by the FDA?

Urinary Catecholamine Kit (K943099) received a 510(k) decision of Substantially Equivalent on October 7, 1994, 100 days after the submission was received.

What is the product code of K943099?

The FDA product code is CHQ – Chromatographic/Fluorometric Method, Catecholamines, a Class I (low risk) device regulated under 21 CFR 862.1165.