Hichem Bun/Urea Reagent Kit

Q: What is the product code of K960115?

The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.

FDA 510(k) K960115 · Elan Pharma, Inc.

Substantially Equivalent

510(k) numberK960115

Submission

Device name: Hichem Bun/Urea Reagent Kit
Applicant: Elan Pharma, Inc.
Brea, CA, US
Received: January 11, 1996
Decision date: March 29, 1996
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1770
Specialty: Clinical Chemistry

Other 510(k)s with product code CDQ

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K203771	Urea Nitrogen2CDQ · Traditional	Abbott Ireland Diagnostics Division	05/31/2022SE
K140690	BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerCDQ · Traditional	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	09/02/2014SE
K110675	Easyra Urea Nitrogen and Creatinine ReagentsCDQ · Traditional	Medica Corp.	04/21/2011SE
K073295	Urea/Bun, Scal, Nortrol, AbtrolCDQ · Traditional	Thermofisher Scientific OY	05/29/2008SE
K070146	Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPCDQ · Traditional	Horiba Abx	10/12/2007SE
K060120	Teco CX3 Reagent Set for Synchron CX SystemCDQ · Traditional	Teco Diagnostics	03/27/2006SE
K041051	Raichem Bun Rate Reagent (Liquid)CDQ · Traditional	Hemagen Diagnostics, Inc.	06/30/2004SE
K024182	Precision Systems Analette Chemistry Analyzer Stanbio Laboratory ReagentsCDQ · Traditional	Precision Systems, Inc.	03/03/2003SE
K021385	Atac Pak Bun ReagentCDQ · Traditional	Elan Diagnostics	07/12/2002SE
K012649	Raichem Bun Rate ReagentCDQ · Traditional	Hemagen Diagnostics, Inc.	10/15/2001SE

More from Hemagen Diagnostics, Inc.

510(k)	Device	Decision
K982469	Hichem Cholesterol Reagent KitCHH · Traditional	08/19/1998SE
K981769	Hichem Phosphorus Reagent KitCEO · Traditional	06/29/1998SE
K962247	Hichem Ck/Nac Reagent KitCGS · Traditional	08/15/1996SE

Questions and answers

When was Hichem Bun/Urea Reagent Kit cleared by the FDA?

Hichem Bun/Urea Reagent Kit (K960115) received a 510(k) decision of Substantially Equivalent on March 29, 1996, 78 days after the submission was received.

What is the product code of K960115?

The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.