Randox RX Daytona Plus Magnesium (MG)— 510(k) K162200

Name: FDA 510(k) clearance K162200
Creator: U.S. Food and Drug Administration
Published: 2017-04-28

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K162200 for Randox RX Daytona Plus Magnesium (MG), Substantially Equivalent on 2017-04-28. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JGJ
Device class: Class 1
Regulation: 21 CFR 862.1495
Advisory panel: Clinical Chemistry
Date received: 2016-08-05
Decision date: 2017-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code JGJ

view all

K181748 — Magnesium2018-09-12
K173294 — Magnesium2018-05-18
K162399 — Atellica CH Magnesium (Mg)2017-01-19
K122302 — ACE MAGNESIUM REGENT2012-08-27
K111915 — MAGNESIUM ASSAY2011-12-02

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
K152085 — Liquid CO2-2 (LCO2-2)2016-02-24
K153435 — Direct HDL Cholesterol (HDL)2016-01-08

Recalls naming K162200

K-number listed on FDA's recall record

Z-0547-2021 — Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326Class II·Terminated·Randox Laboratories Ltd.·20201113

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162200.

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