RANDOX TRANSFERRIN— 510(k) K002585

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K002585 for RANDOX TRANSFERRIN, Substantially Equivalent on 2001-02-05. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DDG
Device class: Class 2
Regulation: 21 CFR 866.5880
Advisory panel: Immunology
Date received: 2000-08-21
Decision date: 2001-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, IE

Download summary PDF View on FDA.gov ↗

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Recalls naming K002585

K-number listed on FDA's recall record

Z-1422-2022 — Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVDClass III·Terminated·Randox Laboratories Ltd.·20220609
Z-1423-2022 — Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVDClass III·Terminated·Randox Laboratories Ltd.·20220609

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002585.

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