Ace Color Test

FDA 510(k) K833933 · Hana Biologics, Inc.

Substantially Equivalent

510(k) numberK833933

Submission

Device name
Ace Color Test
Applicant
Hana Biologics, Inc.
Mchenry, IL, US
Received
November 14, 1983
Decision date
March 23, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KQN – Radioassay, Angiotensin Converting Enzyme
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1090
Specialty
Clinical Chemistry

Other 510(k)s with product code KQN

510(k)DeviceApplicantDecision
K041657Thermo Electron Angiotensin Converting Enzyme Infinity (Ace) ReagentKQN · Traditional Thermo Electron Corporation08/30/2004SE
K942497Angiotensin Converting Enzyme ReaKQN · Traditional American Laboratory Products Co., Ltd.11/15/1994SE
K913091Buehlmann Lab AS, Ace Angio Conv Enzyme Kin AssayKQN · Traditional American Laboratory Products Co., Ltd.08/26/1991SE
K854876Aldosterone Direct Ria KitKQN · Traditional Biotecx Laboratories, Inc.03/17/1986SE
K854245Sigma Angiotensin Converting Enzyme 305-UVKQN · Traditional Sigma Diagnostics, Inc.01/22/1986SE
K821011Ace Activity Microvial Test SetKQN · Traditional Ventrex Laboratories, Inc.05/03/1982SE
K791712Angiotensin Converting Enzyme Assay SysKQN · Traditional Ventrex Laboratories, Inc.09/19/1979SE

More from Ventrex Laboratories, Inc.

510(k)DeviceDecision
K883682Chang Medium (Additional Indications)KIT · Traditional 09/16/1988SE
K855205Mycotrim TM VL Triphasic Culture SystemJSI · Traditional 02/05/1986SE
K834616Amnio Stat-Flm Agglutination TestJHG · Traditional 05/25/1984SE
K822737Mycotrium-RsJSI · Traditional 12/03/1982SE
K822736Mycotrium-GuJSI · Traditional 12/03/1982SE
K822150Amnistat-FlmJHG · Traditional 10/21/1982SE
K812820Chang MediumKIT · Traditional 11/10/1981SE

Questions and answers

When was Ace Color Test cleared by the FDA?

Ace Color Test (K833933) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 130 days after the submission was received.

What is the product code of K833933?

The FDA product code is KQN – Radioassay, Angiotensin Converting Enzyme, a Class II (moderate risk) device regulated under 21 CFR 862.1090.