RANDOX LIPOPROTEIN— 510(k) K011568

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K011568 for RANDOX LIPOPROTEIN, Substantially Equivalent on 2001-09-28. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2001-05-21
Decision date: 2001-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

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Recalls naming K011568

K-number listed on FDA's recall record

Z-1017-2025 — Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403Class II·Ongoing·Randox Laboratories, Limited·20241220
Z-1018-2025 — Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757Class II·Ongoing·Randox Laboratories, Limited·20241220

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011568.

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