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Data / Medical devices / United Kingdom / Randox Laboratories Limited

Randox Laboratories Limited: FDA-registered device maker in ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom, 8 510(k) clearances

Randox Laboratories Limited is registered with the FDA (registration 3014607865) in ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom. It lists 32 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 23, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Randox Laboratories Limited
FDA registration number
3014607865
Address
30 Randalstown Road, ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom, BT41 4FL
Owner or operator
RANDOX LABORATORIES, LTD. (8020890)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
September 22, 2000
Registered through
2026
Brand names listed
ABAXIS CHEMISTRY CONTROL LEVEL 1, ABAXIS CHEMISTRY CONTROL LEVEL 2, ACID WASH SOLUTION (AWS), ACTIVE VITAMIN B12 CONTROL LEVEL 1 (Active Vitamin B12 CONTROL 1), ACTIVE VITAMIN B12 CONTROL LEVEL 2 (Active Vitamin B12 CONTROL 2), ADIPONECTIN CALIBRATOR (ADPN CAL), ADIPONECTIN CONTROL - LEVEL 2 (ADPN CONTROL 2), ADIPONECTIN CONTROL - LEVEL 3 (ADPN CONTROL 3) and more

Devices it lists

DeviceProduct codeClassRoleSource
Albumin, Fitc, Antigen, Antiserum, ControlDDZ2Contract manufactureraccessdata.fda.gov
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, ControlLKL1Contract manufacturer, Manufactureraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Manufactureraccessdata.fda.gov
Assay, Glycosylated HemoglobinLCP2Contract manufactureraccessdata.fda.gov
Blood Specimen Collection Convenience Kit (Excludes Hiv)PQD2Specification developeraccessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And ControlDCK2Manufactureraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Calibrator, SecondaryJIT2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Drug Mixture Control MaterialsDIF1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Manufactureraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Manufactureraccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUManufactureraccessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, ControlDFC2Contract manufactureraccessdata.fda.gov
Multi-Analyte Controls UnassayedOHQ1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/SgotCIT2Manufactureraccessdata.fda.gov
Non-Factor Replacement Product Test SystemSES2Manufactureraccessdata.fda.gov
Photometric Method, MagnesiumJGJ1Manufactureraccessdata.fda.gov
Prealbumin, Antigen, Antiserum, ControlJZJ1Manufactureraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, Beta-2-Microglobulin ImmunologicalJZG2Contract manufactureraccessdata.fda.gov
System, Test, C-Reactive ProteinDCN2Contract manufactureraccessdata.fda.gov
Thin Layer Chromatography, MethamphetamineDJC2Manufactureraccessdata.fda.gov
Urine Collection Kit (Excludes Hiv Testing)OIE1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 23, 2026K250741Evidence MultiSTAT DOA Urine MultiPlexDJGSubstantially EquivalentRandox Laboratories Limitedaccessdata.fda.gov
May 22, 2025DEN240035ConcizuTrace™ ELISASESUnknownRandox Laboratories, Ltd.accessdata.fda.gov
October 5, 2023K221550Evidence MultiSTAT DOA Urine MultiPlexDJGSubstantially EquivalentRandox Laboratories Limitedaccessdata.fda.gov
October 5, 2023K220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATDJGSubstantially EquivalentRandox Laboratories Limitedaccessdata.fda.gov
January 9, 2014K131554RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENTJJESubstantially EquivalentRandox Laboratories, Ltd.accessdata.fda.gov
March 31, 2006K052914RX IMOLACEMSubstantially EquivalentRandox Laboratories, Ltd.accessdata.fda.gov
September 9, 2004K041361RANDOX TRI LEVEL CARDIAC CONTROLJJYSubstantially EquivalentRandox Laboratories Limitedaccessdata.fda.gov
July 31, 1995K953212C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATORDCKSubstantially EquivalentRandox Laboratories, Ltd.accessdata.fda.gov

Compare with other makers

Updated January 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.