RANDOX URIC ACID— 510(k) K033278

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K033278 for RANDOX URIC ACID, Substantially Equivalent on 2004-02-27. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CDO
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 2003-10-10
Decision date: 2004-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDO

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K982251 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT1998-08-18
K981766 — URIC ACID1998-06-19
K981189 — URIC ACID1998-05-07
K971485 — URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)1997-05-27

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Data sourced from openFDA. This site is unofficial and independent of the FDA.