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510(k) K033278

Device
RANDOX URIC ACID
Applicant
Randox Laboratories, Ltd.
510(k) number
K033278
Product code
CDO
Decision
Substantially Equivalent (SESE)
Decision date
2004-02-27
Date received
2003-10-10
Regulation
862.1775
Classification name
Acid, Uric, Uricase (U.V.)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
LYNNE HAMILTON
Address
55 Diamond Rd. Crumlin GB BT29 4QY BT29 4QY

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CDO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100PSigma Diagnostics, Inc.1999-09-28
K981766URIC ACIDAbbott Laboratories1998-06-19
K981189URIC ACIDAbbott Laboratories1998-05-07
K971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.1997-05-27
K955752OLYMPUS URIC ACID REAGENTOlympus America, Inc.1996-01-31
K932162URIC ACID TEST ITEM NUMBER 65422Em Diagnostic Systems, Inc.1993-09-27
K923765SYSTEMATE URICACID TEST, TECHNICON RA 1000Em Diagnostic Systems, Inc.1992-09-22
K903335SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422Em Diagnostic Systems, Inc.1990-08-17
K875320BIOTROL URIC ACID ENZYMATIQUE UV H.P.Biotrol, USA, Inc.1988-02-01
K873358GEMENI URIC ACID U.V.Electro-Nucleonics Laboratories, Inc.1987-09-11
K863660EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95Em Diagnostic Systems, Inc.1986-10-29
K844986ROCHE REAGENTS REAGENT FOR URIC ACIDRoche Diagnostic Systems, Inc.1985-01-18
K822884URIC ACID 75CDOTechnicon Instruments Corp.1982-10-27
K821872ULTRACHEM URIC ACID AIDHHarleco Diagnostics1982-07-14
K821474ULTRACHEM URIC ACID AIDH #65047Emd Chemicals, Inc.1982-06-03