510(k) K043268

Device: SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2
Applicant: RANDOX LABORATORIES, LTD.
510(k) number: K043268
Product code: CEI
Decision: Substantially Equivalent (SESE)
Decision date: 2005-02-15
Date received: 2004-11-26
Regulation: 862.1665
Classification name: Uranyl Acetate/zinc Acetate, Sodium
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 2
Clearance type: Traditional
Statement or summary: Statement
Third party reviewed: No

Applicant Contact#

Contact: P ARMSTRONG
Address: 55 Diamond Rd. Crumlin GB BT29 4QY BT29 4QY

FDA Registration Numbers#

3013660430
3004493545
1832216

Source Documents#

510(k) summary PDF not indicated by FDA

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
05055273209310	Na	RANDOX LABORATORIES LIMITED	2016-09-16
05055273204704	Na	RANDOX LABORATORIES LIMITED	2016-09-16
05055273204698	Na	RANDOX LABORATORIES LIMITED	2016-09-16

Other 510(k) Records For Product Code CEI #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K914039	SODIUM REAGENT SET	Sterling Diagnostics, Inc.	1991-10-31
K902572	SODIUM REAGENT SET	Tech Intl. Co.	1990-07-10
K832552	SODIUM TEST KIT	Mallinckrodt Critical Care	1983-09-20

Legacy Summary#

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FDA Review#

Decision Summary