RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2— 510(k) K110846

Name: FDA 510(k) clearance K110846
Creator: U.S. Food and Drug Administration
Published: 2011-09-30

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K110846 for RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2, Substantially Equivalent on 2011-09-30. Applicant: Randox Laboratories Limited. Device class: 1.

Clearance details

Applicant: Randox Laboratories Limited
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2011-03-28
Decision date: 2011-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJW

view all

K170091 — UA-Cellular Complete2017-02-09
K142262 — AUTION CHECK PLUS2015-04-10
K131444 — UA-CELLULAR COMPLETE2014-01-29
K103387 — MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL2011-02-02
K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 22009-01-16

More clearances from Randox Laboratories Limited

view all

K250741 — Evidence MultiSTAT DOA Urine MultiPlex2026-01-23
K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT2023-10-05
K221550 — Evidence MultiSTAT DOA Urine MultiPlex2023-10-05
K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP)2017-04-21
K161691 — Direct LDL Cholesterol (LDL)2017-03-20

Recalls naming K110846

K-number listed on FDA's recall record

Z-2557-2019 — Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.Class III·Terminated·Randox Laboratories Ltd.·20190725

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110846.

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