RANDOX MAGNESIUM— 510(k) K974606

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K974606 for RANDOX MAGNESIUM, Substantially Equivalent on 1998-02-12. 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: 1997-12-10
Decision date: 1998-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, IE

Download summary PDF View on FDA.gov ↗

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Recalls naming K974606

K-number listed on FDA's recall record

Z-0546-2021 — Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880Class 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 K974606.

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