RANDOX MICROALBUMIN— 510(k) K002674

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K002674 for RANDOX MICROALBUMIN, Substantially Equivalent on 2000-10-05. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DDZ
Device class: Class 2
Regulation: 21 CFR 866.5040
Advisory panel: Immunology
Date received: 2000-08-28
Decision date: 2000-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, IE

Download summary PDF View on FDA.gov ↗

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Recalls naming K002674

K-number listed on FDA's recall record

Z-1594-2024 — Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426Class II·Ongoing·Randox Laboratories Ltd.·20240131

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002674.

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