Cleared Traditional

RANDOX URIC ACID

K033278 · Randox Laboratories, Ltd. · Chemistry
Feb 2004
Decision
140d
Days
Class 1
Risk

About This 510(k) Submission

K033278 is an FDA 510(k) clearance for the RANDOX URIC ACID, a Acid, Uric, Uricase (u.v.) (Class I — General Controls, product code CDO), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on February 27, 2004, 140 days after receiving the submission on October 10, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.

Submission Details

510(k) Number K033278 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2003
Decision Date February 27, 2004
Days to Decision 140 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CDO — Acid, Uric, Uricase (u.v.)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1775

Similar Devices — CDO Acid, Uric, Uricase (u.v.)

All 30
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
K992798 · Sigma Diagnostics, Inc. · Sep 1999
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
K982251 · Sigma Diagnostics, Inc. · Aug 1998
URIC ACID
K981766 · Abbott Laboratories · Jun 1998
URIC ACID
K981189 · Abbott Laboratories · May 1998
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K971485 · Trace America, Inc. · May 1997
OLYMPUS URIC ACID REAGENT
K955752 · Olympus America, Inc. · Jan 1996