Hichem Phosphorus Reagent Kit

Q: What is the product code of K981769?

The FDA product code is CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus, a Class I (low risk) device regulated under 21 CFR 862.1580.

FDA 510(k) K981769 · Elan Pharma, Inc.

Substantially Equivalent

510(k) numberK981769

Submission

Device name: Hichem Phosphorus Reagent Kit
Applicant: Elan Pharma, Inc.
Brea, CA, US
Received: May 19, 1998
Decision date: June 29, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device class: Class I (low risk)
Regulation: 21 CFR 862.1580
Specialty: Clinical Chemistry

Other 510(k)s with product code CEO

510(k)	Device	Applicant	Decision
K100263	Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsCEO · Traditional	Seppim S.A.S.	05/06/2011SE
K072141	S40 Clinical Analyzer, S Test Ip, S Test UaCEO · Traditional	Alfa Wassermann Diagnostic Technologies, Inc.	06/24/2008SE
K041643	Synchron Systems Phosphorus (PHS) ReagentCEO · Traditional	Beckman Coulter, Inc.	08/18/2004SE
K030015	Atac Pak Phosphorus ReagentCEO · Traditional	Elan Diagnostics	03/07/2003SE
K022312	Piccolo Phosphorus Test SystemCEO · Traditional	Abaxis, Inc.	09/05/2002SE
K013095	Wiener Lab.Fosfatemia UV, Models 1X100 ML Cat.N 1382321, 4X20 ML Cat.N 1009311CEO · Traditional	Wiener Laboratories Saic	11/16/2001SE
K003912	Phosphorus ReagentCEO · Traditional	Jas Diagnostics, Inc.	02/21/2001SE
K003012	Raichem Phosporus ReagentCEO · Special	Hemagen Diagnostics, Inc.	10/25/2000SE
K991867	Inorganic Phosphorus (Ip), Product No's, 112-01, 112-02CEO · Traditional	A.P. Total Care, Inc.	08/02/1999SE
K983503	Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional	Boehringer Mannheim Corp.	12/01/1998SE

More from Boehringer Mannheim Corp.

510(k)	Device	Decision
K982469	Hichem Cholesterol Reagent KitCHH · Traditional	08/19/1998SE
K962247	Hichem Ck/Nac Reagent KitCGS · Traditional	08/15/1996SE
K960115	Hichem Bun/Urea Reagent KitCDQ · Traditional	03/29/1996SE

Questions and answers

When was Hichem Phosphorus Reagent Kit cleared by the FDA?

Hichem Phosphorus Reagent Kit (K981769) received a 510(k) decision of Substantially Equivalent on June 29, 1998, 41 days after the submission was received.

What is the product code of K981769?

The FDA product code is CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus, a Class I (low risk) device regulated under 21 CFR 862.1580.