Company · GB
Randox Laboratories, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2026. Name variants (Inc, Corp, punctuation) are merged.
134510(k) clearances (1 in 12 months)
98recalls (0 in 12 months)
77recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 46 |
| JIX | Calibrator, Multi-Analyte Mixture | 15 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 7 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 6 |
| CGA | Glucose Oxidase, Glucose | 5 |
| DJG | Enzyme Immunoassay, Opiates | 5 |
| JGJ | Photometric Method, Magnesium | 5 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 4 |
| CEM | Electrode, Ion Specific, Potassium | 4 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 4 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 4 |
| CJY | Azo Dye, Calcium | 4 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 4 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 3 |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 3 |
| DDG | Transferrin, Antigen, Antiserum, Control | 3 |
| DHR | System, Test, Rheumatoid Factor | 3 |
| DJR | Enzyme Immunoassay, Methadone | 3 |
| JFM | Enzymatic Method, Bilirubin | 3 |
| JIF | Enzymatic Method, Ammonia | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 23, 2026 | K250741 | Evidence MultiSTAT DOA Urine MultiPlex Randox Laboratories Limited, GB | DJG |
| May 22, 2025 | DEN240035 | ConcizuTrace ELISA Randox Laboratories, Ltd., GB | SES |
| Oct 5, 2023 | K221550 | Evidence MultiSTAT DOA Urine MultiPlex Randox Laboratories Limited, GB | DJG |
| Oct 5, 2023 | K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT Randox Laboratories Limited, GB | DJG |
| Sep 8, 2023 | K230890 | ISE Electrodes Randox Laboratories, Ltd., GB | CEM |
| Oct 23, 2018 | K182042 | Randox Calcium (Ca) Randox Laboratories, Ltd., GB | CJY |
| Apr 28, 2017 | K162200 | Randox RX Daytona Plus Magnesium (MG) Randox Laboratories, Ltd., GB | JGJ |
| Apr 21, 2017 | K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) Randox Laboratories Limited, GB | CJE |
| Mar 20, 2017 | K161691 | Direct LDL Cholesterol (LDL) Randox Laboratories Limited, GB | MRR |
| Feb 24, 2016 | K152085 | Liquid CO2-2 (LCO2-2) Randox Laboratories, Ltd., GB | KHS |
| Feb 16, 2016 | K152343 | Direct Bilirubin Randox Laboratories Limited, GB | JFM |
| Jan 28, 2016 | K152344 | Total Bilirubin Randox Laboratories Limited, GB | JFM |
| Jan 8, 2016 | K153435 | Direct HDL Cholesterol (HDL) Randox Laboratories, Ltd., GB | LBS |
| Sep 29, 2015 | K150654 | Cholesterol Randox Laboratories, Ltd., GB | CHH |
| Aug 6, 2015 | K150819 | Triglycerides Randox Laboratories Limited, GB | CDT |
| Dec 8, 2014 | K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. Randox Laboratories Limited, GB | JJY |
| Sep 18, 2014 | K142181 | RANDOX ALDOLASE CALIBRATION SERUM Randox Laboratories Limited, GB | JIT |
| May 22, 2014 | K140522 | RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL Randox Laboratories Limited, GB | JJY |
| Mar 25, 2014 | K140393 | RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 Randox Laboratories Limited, GB | JJY |
| Jan 9, 2014 | K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT Randox Laboratories, Ltd., GB | JJE |
| Nov 21, 2013 | K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR Randox Laboratories, Ltd., GB | CGS |
| Oct 23, 2013 | K132156 | RANDOX CSF CONTROLS LEVELS 2 AND 3 Randox Laboratories, Ltd., GB | JJY |
| Aug 8, 2013 | K132090 | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 Randox Laboratories, Ltd., GB | DLJ |
| Jul 26, 2013 | K131999 | HBA1C CONTROL, LEVEL 1 AND LEVEL 2 Randox Laboratories, Ltd., GB | JJX |
| Jul 18, 2013 | K131776 | ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 Randox Laboratories, Ltd., GB | JJX |
| Jun 19, 2013 | K130337 | RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 Randox Laboratories Limited, GB | JJY |
| Nov 20, 2012 | K121603 | RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 Randox Laboratories, Ltd., GB | JJY |
| Sep 20, 2012 | K113720 | RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 Randox Laboratories, Ltd., GB | JJY |
| Aug 24, 2012 | K113747 | RANDOX OPIATES ASSAY Randox Laboratories Limited, GB | DJG |
| Aug 14, 2012 | K122126 | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR Randox Laboratories Limited, GA | JIS |
| Jul 11, 2012 | K121746 | RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) Randox Laboratories, Ltd., GB | JJX |
| Jun 20, 2012 | K121588 | RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 Randox Laboratories, Ltd., GB | JJX |
| May 8, 2012 | K113751 | RANDOX COCAINE METABOLITE Randox Laboratories, Ltd., GB | DIO |
| Jan 23, 2012 | K110534 | RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 Randox Laboratories Limited, GB | JJY |
| Dec 1, 2011 | K112337 | RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL Randox Laboratories, Ltd., GB | JJY |
| Oct 14, 2011 | K102346 | RANDOX DIGOXIN ASSAY Randox Laboratories, Ltd., GB | KXT |
| Sep 30, 2011 | K110904 | RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 Randox Laboratories, Ltd., GB | JJY |
| Sep 30, 2011 | K110846 | RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 Randox Laboratories Limited, GB | JJW |
| May 25, 2011 | K092268 | RANDOX BARITURATES ASSAY Randox Laboratories, Ltd., GB | DIS |
| May 9, 2011 | K092266 | RANDOX METHAMPHETAMINE ASSAY Randox Laboratories, Ltd., GB | DKB |
| Apr 8, 2011 | K092269 | CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET Randox Laboratories, Ltd., GB | LDJ |
| Mar 1, 2011 | K092275 | RANDOX ECSTASY (MDMA) ASSAY Randox Laboratories, Ltd., GB | DKZ |
| Nov 18, 2010 | K092272 | RANDOX METHADONE ASSAY Randox Laboratories, Ltd., GB | DJR |
| Nov 9, 2010 | K092258 | RANDOX METABOLITE (EDDP) ASSAY Randox Laboratories, Ltd., GB | DJR |
| Nov 1, 2010 | K092273 | RANDOX ETHANOL ASSAY Randox Laboratories, Ltd., GB | DIC |
| Oct 15, 2010 | K092274 | RANDOX BENZODIAZEPINE ASSAY Randox Laboratories, Ltd., GB | JXM |
| Jul 20, 2006 | K061056 | RANDOX LIQUID PROTEIN CALIBRATOR Randox Laboratories, Ltd., GB | JIX |
| Mar 31, 2006 | K052914 | RX IMOLA Randox Laboratories, Ltd., GB | CEM |
| Jan 13, 2006 | K053153 | RANDOX CALIBRATION SERUM Randox Laboratories, Ltd., GB | JIX |
| May 17, 2005 | K050179 | RANDOX BENZODIAZEPINE CLASS ASSAY Randox Laboratories, Ltd., GB | JXM |
Newest 50 of 134.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2025 | Randox Laboratories, Limited Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers.
Catalog Number: LP2757 Open, Classified |
DFC | K011568 |
| Jan 23, 2025 | Randox Laboratories, Limited Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers.
Catalog Number: LP3403 Open, Classified |
DFC | K011568 |
| Sep 30, 2024 | Randox Laboratories CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum
Catalogue number: CP3826 Open, Classified |
DCK | K953212 |
| Jul 24, 2024 | Randox Laboratories Ltd. RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers.
Catalogue Number: CYS4004 Open, Classified |
NDY | None listed |
| May 9, 2024 | Randox Laboratories Ltd. Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination
of parent drug molecule and metabolites of drugs in human urine
Catalog Number: EV4115 Open, Classified |
JJE | K220451 |
| May 3, 2024 | Randox Laboratories Ltd. Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests. Open, Classified |
JIX | K053153 |
| Apr 17, 2024 | Randox Laboratories Ltd. Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay
Catalog Number: MA2426 Open, Classified |
DDZ | K002674 |
| Apr 17, 2024 | Randox Laboratories Ltd. Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay
Catalog Number: MA1567 Open, Classified |
JIT | None listed |
| Mar 22, 2024 | Randox Laboratories Ltd. Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers
Catalog Number: CVS 2699 Open, Classified |
NDY | None listed |
| Mar 20, 2024 | Randox Laboratories Ltd. Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution. Open, Classified |
JIX | K061056 |
| Feb 6, 2024 | Randox Laboratories Ltd. RX Series Copper (Cu) Assay Ref. Number CU2340 Open, Classified |
JKZ | None listed |
| Jan 18, 2024 | Randox Laboratories Ltd. Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays
Catalog Number: CAL2351 Open, Classified |
JIX | K053153 |
| Jan 18, 2024 | Randox Laboratories Ltd. Calibration Serum Level 3
CAL2351 Open, Classified |
JIX | K053153 |
| Jan 18, 2024 | Randox Laboratories Ltd. Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532) Open, Classified |
JIX | K053153 |
| Jan 2, 2024 | Randox Laboratories Ltd. SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxopla Open, Classified |
OHQ | None listed |
| Dec 6, 2023 | Randox Laboratories Ltd. RANDOX Total Bilirubin. Open, Classified |
JFM | K152344 |
| Oct 31, 2023 | Randox Laboratories Ltd. RX Monaco-IVD Clinical Chemistry Analyser
Catalog Number: RX5000 Open, Classified |
CGA | None listed |
| Oct 31, 2023 | Randox Laboratories Ltd. RX Modena-IVD Clinical Chemistry Analyser
Catalog Number: RX9000 Open, Classified |
CGA | None listed |
| Oct 31, 2023 | Randox Laboratories Ltd. RX Imola-IVD Clinical Chemistry Analyzer
Catalog Number: RX4900. RX4900R (refurbished) Open, Classified |
CEM | K052914 |
| Oct 31, 2023 | Randox Laboratories Ltd. RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser
(1) RX4041, (2) RX4041R (refurbished) Open, Classified |
CIT | K131554 |
| Oct 31, 2023 | Randox Laboratories Ltd. RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser
Catalog Number: RX4040 Open, Classified |
CGA | K024014 |
| Sep 19, 2023 | Randox Laboratories Ltd. Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 Open, Classified |
JJY | K140971 |
| Aug 23, 2023 | Randox Laboratories Ltd. Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferri Open, Classified |
JIX | K061056 |
| Aug 23, 2023 | Randox Laboratories Ltd. Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Open, Classified |
JJY | K110904 |
| Aug 9, 2023 | Randox Laboratories Ltd. Randox RX Series Urea Enzymatic Kinetic Assay
Ref. Numbers:
(1) UR3825
(2) UR3873
(3) UR8334
(4) UR8070 (Modena) Open, Classified |
CDQ | K923506 |
| Jun 28, 2023 | Randox Laboratories Ltd. Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes
Catalog Number: IA2633 Open, Classified |
JJY | K140522 |
| Jun 28, 2023 | Randox Laboratories Ltd. Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes.
Catalog Number: IA2640 Open, Classified |
JJY | K140522 |
| Jan 5, 2023 | Randox Laboratories Ltd. Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems
Catalog Number: PS2684 Open, Classified |
JJY | K972608 |
| Jan 5, 2023 | Randox Laboratories Ltd. Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems
Catalog Number: PS2683 Open, Classified |
JJY | K972608 |
| Jan 5, 2023 | Randox Laboratories Ltd. Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems
Catalog Number: PS2682
Control Level 1 Open, Classified |
JJY | K972608 |
| Dec 3, 2022 | Randox Laboratories Ltd. IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma
Catalog Number: IM3834 Terminated |
DFT | K955797 |
| Dec 3, 2022 | Randox Laboratories Ltd. IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma
Catalog Number: IA3832 Terminated |
CZP | K955794 |
| Sep 19, 2022 | Randox Laboratories Ltd. The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is de Terminated |
OHQ | None listed |
| Jun 22, 2022 | Randox Laboratories Ltd. Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma.
Catalog Number: CH2O0 Terminated |
CHH | K923504 |
| Jun 9, 2022 | Randox Laboratories Ltd. Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD Terminated |
DDG | K002585 |
| Jun 9, 2022 | Randox Laboratories Ltd. Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD Terminated |
DDG | K002585 |
| Mar 25, 2022 | Randox Laboratories Ltd. CK MB Calibrator, Catalogue Number CK2393 Terminated |
CGS | None listed |
| Nov 1, 2021 | Randox Laboratories Ltd. RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum
REF: CH200 Terminated |
CHH | K923504 |
| May 10, 2021 | Randox Laboratories Ltd. NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA
Catalog Number: FA115 Terminated |
JLH | None listed |
| Apr 28, 2021 | Randox Laboratories Ltd. Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R Terminated |
CEM | None listed |
| Mar 29, 2021 | Randox Laboratories Ltd. Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator.
Catalogue Number: CAL2351 Terminated |
JIX | K053153 |
| Nov 13, 2020 | Randox Laboratories Ltd. Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine
Catalogue Number: MG8326 Terminated |
JGJ | K162200 |
| Nov 13, 2020 | Randox Laboratories Ltd. Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine
Catalogue Number: MG3880 Terminated |
JGJ | K974606 |
| Aug 11, 2020 | Randox Laboratories Ltd. Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This pro Terminated |
CFJ | K970684 |
| Aug 11, 2020 | Randox Laboratories Ltd. Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. T Terminated |
CFJ | K970684 |
| Aug 4, 2020 | RANDOX LABORATORIES, LTD. Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma. Terminated |
CHI | None listed |
| Aug 4, 2020 | RANDOX LABORATORIES, LTD. Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma. Terminated |
CHI | None listed |
| Aug 4, 2020 | RANDOX LABORATORIES, LTD. Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma. Terminated |
CHI | None listed |
| Jul 30, 2020 | RANDOX LABORATORIES, LTD. AM1054 Randox Ammonia (NH3), Enzymatic UV Method
For the quantitative in vitro determination of Ammonia in plasma Terminated |
JIF | K030873 |
| Jul 30, 2020 | RANDOX LABORATORIES, LTD. AM1015 Randox Ammonia (NH3), Enzymatic UV Method
For the quantitative in vitro determination of Ammonia in plasma Terminated |
JIF | K030873 |
Newest 50 of 98.