CAT-3 Catecholamine Assay Kit

FDA 510(k) K855214 · Whale Scientific, Inc.

Substantially Equivalent

510(k) numberK855214

Submission

Device name
CAT-3 Catecholamine Assay Kit
Applicant
Whale Scientific, Inc.
Commerce City, CO, US
Received
December 30, 1985
Decision date
March 14, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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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
K943099Urinary Catecholamine KitCHQ · Traditional Bioanalytical Systems, Inc.10/07/1994SE
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

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510(k)DeviceDecision
K841506META-3 · Traditional 04/11/1984SESP
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Questions and answers

When was CAT-3 Catecholamine Assay Kit cleared by the FDA?

CAT-3 Catecholamine Assay Kit (K855214) received a 510(k) decision of Substantially Equivalent on March 14, 1986, 74 days after the submission was received.

What is the product code of K855214?

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