510(k) K100263

Device: ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
Applicant: SEPPIM S.A.S.
510(k) number: K100263
Product code: CEO
Decision: Substantially Equivalent (SESE)
Decision date: 2011-05-06
Date received: 2010-01-28
Regulation: 862.1580
Classification name: Phosphomolybdate (colorimetric), Inorganic Phosphorus
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K072141	S40 CLINICAL ANALYZER, S TEST IP, S TEST UA	Alfa Wassermann Diagnostic Technologies, Inc.	2008-06-24
K041643	SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT	Beckman Coulter, Inc.	2004-08-18
K030015	ATAC PAK PHOSPHORUS REAGENT	Elan Diagnostics	2003-03-07
K022312	PICCOLO PHOSPHORUS TEST SYSTEM	Abaxis, Inc.	2002-09-05
K013095	WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311	Wiener Laboratories Saic	2001-11-16
K003912	PHOSPHORUS REAGENT	Jas Diagnostics, Inc.	2001-02-21
K003012	RAICHEM PHOSPORUS REAGENT	Hemagen Diagnostics, Inc.	2000-10-25
K991867	INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02	A.P. Total Care, Inc.	1999-08-02
K983503	ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347	Boehringer Mannheim Corp.	1998-12-01
K981769	HICHEM PHOSPHORUS REAGENT KIT	Elan Pharma, Inc.	1998-06-29
K981610	CARESIDE ANALYZER	Careside, Inc.	1998-06-25
K981759	PHOS	Abbott Laboratories	1998-06-16
K981118	PHOS	Abbott Laboratories	1998-06-12
K974858	PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30	Diagnostic Chemicals , Ltd.	1998-01-30
K974605	RANDOX INORGANIC PHOSPHOROUS	Randox Laboratories, Ltd.	1998-01-09

summary

Decision Summary