UREA KIT— 510(k) K923506

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K923506 for UREA KIT, Substantially Equivalent on 1993-09-27. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1992-07-15
Decision date: 1993-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antrim, N. Ireland, IR

Download summary PDF View on FDA.gov ↗

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Recalls naming K923506

K-number listed on FDA's recall record

Z-2362-2023 — Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)Class II·Ongoing·Randox Laboratories Ltd.·20230613

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K923506.

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