URIC ACID ENZYMATIC COLORIMERIC KIT— 510(k) K923503

Name: FDA 510(k) clearance K923503
Creator: U.S. Food and Drug Administration
Published: 1993-07-22

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K923503 for URIC ACID ENZYMATIC COLORIMERIC KIT, Substantially Equivalent on 1993-07-22. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code KNK
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1992-07-15
Decision date: 1993-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antrim, N. Ireland, IR

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNK

view all

K102568 — URIC ACID MODEL 3P392011-05-06
K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X982007-04-06
K040467 — VITALAB URIC ACID REAGENT2004-03-08
K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR2003-07-15
K022096 — URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM2003-03-18

More clearances from Randox Laboratories, Ltd.

view all

DEN240035 — ConcizuTrace ELISA2025-05-22
K230890 — ISE Electrodes2023-09-08
K182042 — Randox Calcium (Ca)2018-10-23
K162200 — Randox RX Daytona Plus Magnesium (MG)2017-04-28
K152085 — Liquid CO2-2 (LCO2-2)2016-02-24

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