Data / Medical devices / United Kingdom / Randox Laboratories Limited

Randox Laboratories Limited: FDA-registered device maker in CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom, 134 510(k) clearances

Name: Randox Laboratories Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Randox Laboratories Limited is registered with the FDA (registration 3004493545) in CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom. It lists 124 device types. The FDA files 134 510(k) clearances under its listings, the newest dated January 23, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Randox Laboratories Limited

FDA registration number: 3004493545
Address: 36 / 44 Largy Road, CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom, BT29 4RN
Owner or operator: RANDOX LABORATORIES, LTD. (8020890)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: March 4, 1997
Registered through: 2026
Brand names listed: 3), ABAXIS CHEMISTRY CONTROL LEVEL 1, ABAXIS CHEMISTRY CONTROL LEVEL 2, ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72, 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) and more

Devices it lists

Device	Product code	Class	Role	Source
Acid Phosphatase, Naphthyl Phosphate	CKB	2	Contract manufacturer	accessdata.fda.gov
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase	JMK	1	Manufacturer	accessdata.fda.gov
Acid, Lactic, Enzymatic Method	KHP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)	KNK	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Albumin, Fitc, Antigen, Antiserum, Control	DDZ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Alkaline Picrate, Colorimetry, Creatinine	CGX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	LKL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, Control	DEM	2	Contract manufacturer	accessdata.fda.gov
Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes	CJO	2	Contract manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Analyzer, Chemistry, Micro, For Clinical Use	JJF	1	Manufacturer	accessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Apolipoproteins	MSJ	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Assay, Glutathione Reductase	KQF	2	Manufacturer	accessdata.fda.gov
Assay, Glycosylated Hemoglobin	LCP	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Atomic Absorption, Lithium	JII	2	Manufacturer	accessdata.fda.gov
Atp And Creatine Kinase (Enzymatic), Creatine	JLB	1	Manufacturer	accessdata.fda.gov
Azo Dye, Calcium	CJY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Manufacturer	accessdata.fda.gov
Biuret (Colorimetric), Total Protein	CEK	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Blood Specimen Collection Convenience Kit (Excludes Hiv)	PQD	2	Specification developer	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Calibrator, Primary	JIS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Calibrators, Drug Mixture	DKB	2	Contract manufacturer	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	NQD	2	Contract manufacturer	accessdata.fda.gov
Catalytic Methods, Amylase	JFJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Colorimetric Method, Gamma-Glutamyl Transpeptidase	JPZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Colorimetry, Cholinesterase	DIH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Complement C3, Antigen, Antiserum, Control	CZW	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Complement C4, Antigen, Antiserum, Control	DBI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Control, Hemoglobin	GGM	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Controls For Blood-Gases, (Assayed And Unassayed)	JJS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids	JLG	1	Manufacturer	accessdata.fda.gov
Cresolphthalein Complexone, Calcium	CIC	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Contract manufacturer	accessdata.fda.gov
Drug Mixture Control Materials	DIF	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Drug Specific Control Materials	LAS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes	JQA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzymatic (Glutathione Reductase), Glutathione	JLO	1	Manufacturer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzymatic Method, Ammonia	JIF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzymatic Method, Bilirubin	JFM	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Contract manufacturer	accessdata.fda.gov
Enzymatic, Carbon-Dioxide	KHS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Controls (Assayed And Unassayed)	JJT	1	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Carbamazepine	KLT	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Digitoxin	LFM	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Digoxin	KXT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Diphenylhydantoin	DIP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Gentamicin	LCD	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Phenobarbital	DLZ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Theophylline	KLS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Valproic Acid	LEG	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase	CJC	1	Manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Haptoglobin, Antigen, Antiserum, Control	DAD	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hemoglobinometer	GIG	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Hexokinase, Glucose	CFR	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Hydrazone Colorimetry, Ast/Sgot	CIS	2	Manufacturer	accessdata.fda.gov
Iga, Antigen, Antiserum, Control	CZP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Ige, Antigen, Antiserum, Control	DGC	2	Manufacturer	accessdata.fda.gov
Igg, Antigen, Antiserum, Control	DEW	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Igm, Antigen, Antiserum, Control	DFT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Immunochemical, Transferrin	JNM	2	Contract manufacturer	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, Lipase	CHI	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, Control	DFC	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Method, Nephelometric, Immunoglobulins (G, A, M)	CFN	2	Contract manufacturer	accessdata.fda.gov
Microtitrator, For Clinical Use	JRA	1	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls Unassayed	OHQ	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Myoglobin, Antigen, Antiserum, Control	DDR	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	CGS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nephelometric, Amylase	KHM	2	Contract manufacturer	accessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	2	Manufacturer	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Manufacturer	accessdata.fda.gov
Non-Factor Replacement Product Test System	SES	2	Manufacturer	accessdata.fda.gov
Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes	CJK	2	Contract manufacturer	accessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Photometric Method, Iron (Non-Heme)	JIY	1	Contract manufacturer	accessdata.fda.gov
Photometric Method, Magnesium	JGJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Prealbumin, Antigen, Antiserum, Control	JZJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Radioimmunoassay, Amikacin	KLQ	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Vancomycin	LEH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Manufacturer	accessdata.fda.gov
Saccharogenic, Amylase	CIJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Beta-2-Microglobulin Immunological	JZG	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, C-Reactive Protein	DCN	2	Contract manufacturer	accessdata.fda.gov
System, Test, Low Density, Lipoprotein	MRR	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Test, Cystatin C	NDY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tetraphenyl Borate, Colorimetry, Potassium	CEJ	2	Manufacturer	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Manufacturer	accessdata.fda.gov
Titrimetric, Fatty Acids	JLH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Titrimetric, Magnesium	CFO	1	Contract manufacturer	accessdata.fda.gov
Transferrin, Antigen, Antiserum, Control	DDG	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Turbidimetric Method, Lipoproteins	JHN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Uranyl Acetate/Zinc Acetate, Sodium	CEI	2	Manufacturer	accessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Urinalysis Controls (Assayed And Unassayed)	JJW	1	Manufacturer	accessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test System	LPS	2	Manufacturer, Repackager or relabeler	accessdata.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. Newest 100 of 134.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 23, 2026	K250741	Evidence MultiSTAT DOA Urine MultiPlex	DJG	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
May 22, 2025	DEN240035	ConcizuTrace ELISA	SES	Unknown	Randox Laboratories, Ltd.	accessdata.fda.gov
October 5, 2023	K221550	Evidence MultiSTAT DOA Urine MultiPlex	DJG	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
October 5, 2023	K220451	Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT	DJG	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
September 8, 2023	K230890	ISE Electrodes	CEM	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
October 23, 2018	K182042	Randox Calcium (Ca)	CJY	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
April 28, 2017	K162200	Randox RX Daytona Plus Magnesium (MG)	JGJ	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
April 21, 2017	K162275	Randox RX Daytona Plus Alkaline Phosphatase (ALP)	CJE	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
March 20, 2017	K161691	Direct LDL Cholesterol (LDL)	MRR	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
February 24, 2016	K152085	Liquid CO2-2 (LCO2-2)	KHS	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
February 16, 2016	K152343	Direct Bilirubin	JFM	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
January 28, 2016	K152344	Total Bilirubin	JFM	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
January 8, 2016	K153435	Direct HDL Cholesterol (HDL)	LBS	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
September 29, 2015	K150654	Cholesterol	CHH	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
August 6, 2015	K150819	Triglycerides	CDT	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
December 8, 2014	K140971	LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.	JJY	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
September 18, 2014	K142181	RANDOX ALDOLASE CALIBRATION SERUM	JIT	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
May 22, 2014	K140522	RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL	JJY	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
March 25, 2014	K140393	RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3	JJY	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
January 9, 2014	K131554	RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT	JJE	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
November 21, 2013	K123977	RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR	CGS	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
October 23, 2013	K132156	RANDOX CSF CONTROLS LEVELS 2 AND 3	JJY	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
July 26, 2013	K131999	HBA1C CONTROL, LEVEL 1 AND LEVEL 2	JJX	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
July 18, 2013	K131776	ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3	JJX	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
June 19, 2013	K130337	RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3	JJY	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
November 20, 2012	K121603	RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3	JJY	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
October 3, 2012	K122599	ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR	DDR	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
September 20, 2012	K113720	RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3	JJY	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
August 24, 2012	K113747	RANDOX OPIATES ASSAY	DJG	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
August 14, 2012	K122126	DIRECT LDL/HDL CHOLESTEROL CALIBRATOR	JIS	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
July 11, 2012	K121746	RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)	JJX	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
June 20, 2012	K121588	RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3	JJX	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
December 1, 2011	K112337	RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL	JJY	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
October 14, 2011	K102346	RANDOX DIGOXIN ASSAY	KXT	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
September 30, 2011	K110904	RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3	JJY	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
September 30, 2011	K110846	RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2	JJW	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
August 17, 2011	K110736	ADVIA CHEMISTRY FERRITIN (FRT) METHOD	DBF	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
May 17, 2011	K110188	DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT	LCP	Substantially Equivalent	Diazyme Laboratories	accessdata.fda.gov
March 1, 2011	K092275	RANDOX ECSTASY (MDMA) ASSAY	DKZ	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
February 18, 2011	K103701	ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS	JIX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
March 10, 2010	K093384	MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)	JJY	Substantially Equivalent	Diamond Diagnostics, Inc.	accessdata.fda.gov
July 31, 2009	K083222	AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100	LPS	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.	accessdata.fda.gov
April 2, 2009	K083386	ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)	CJY	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
March 11, 2009	K083906	ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487	NDY	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
June 2, 2008	K080973	CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC	JJY	Substantially Equivalent	Cliniqa Corporation	accessdata.fda.gov
December 7, 2007	K063845	ADVIA CHEMISTRY TOTAL BILIRUBIN_2	JFM	Substantially Equivalent	Bayer Healthcare, LLC	accessdata.fda.gov
October 5, 2007	K072204	ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS	JIX	Substantially Equivalent	Siemens Medical Solutions Diagnostics	accessdata.fda.gov
July 20, 2006	K061056	RANDOX LIQUID PROTEIN CALIBRATOR	JIX	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
March 31, 2006	K052914	RX IMOLA	CEM	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
December 30, 2005	K053132	WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791	JFM	Substantially Equivalent	Wako Chemicals USA, Inc.	accessdata.fda.gov
February 15, 2005	K043268	SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2	CEI	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
February 15, 2005	K043266	RANDOX URINE CONTROLS	JJW	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
February 10, 2005	K043267	POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2	CEJ	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
October 29, 2004	K042448	DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT	JJX	Substantially Equivalent	General Atomics	accessdata.fda.gov
September 9, 2004	K041361	RANDOX TRI LEVEL CARDIAC CONTROL	JJY	Substantially Equivalent	Randox Laboratories Limited	accessdata.fda.gov
August 16, 2004	K041898	CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM	JJX	Substantially Equivalent	Cliniqa Corporation	accessdata.fda.gov
June 16, 2004	K040379	RANDOX IMMUNOASSAY CONTROL	JJY	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
June 9, 2004	K033884	RANDOX AMIKACIN	KLQ	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
May 17, 2004	K040927	LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS	JJX	Substantially Equivalent	Cliniqa Corporation	accessdata.fda.gov
March 12, 2004	K040351	RANDOX LIQUID CRP CONTROLS	JJX	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
December 23, 2003	K033360	DIAZYME LITHIUM ENZYMATIC ASSAY KIT	JII	Substantially Equivalent	General Atomics	accessdata.fda.gov
December 4, 2003	K024014	RANDOX RX DAYTONA	CGA	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
August 8, 2003	K031608	RANDOX LIQUID PROTEIN CALIBRATOR	JIX	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
July 23, 2003	K031575	LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS	JJY	Substantially Equivalent	Cliniqa Corporation	accessdata.fda.gov
May 12, 2003	K030873	RANDOX AMMONIA	JIF	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
March 13, 2003	K030566	LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS	JJY	Substantially Equivalent	Cliniqa Corporation	accessdata.fda.gov
January 13, 2003	K023763	RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS	LCP	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
December 24, 2002	K023841	AMMONIA ASSAY FOR THE ADVIA 1650	JIF	Substantially Equivalent	Bayer Diagnostics Corp.	accessdata.fda.gov
November 26, 2002	K021897	RANDOX HAEMOGLOBIN A1C	LCP	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
November 5, 2002	K022682	RANDOX C-REACTIVE PROTEIN CALIBRATOR	JIS	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
October 24, 2002	K023158	RANDOX APOLIPOPROTEIN CALIBRATOR	JIX	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
October 2, 2002	K022885	LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE	JJY	Substantially Equivalent	Cliniqa Corporation	accessdata.fda.gov
August 30, 2002	K022591	RANDOX LIPID CONTROL	JJY	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
June 14, 2002	K021484	HEMOGLOBIN A1C CONTROL	LCP	Substantially Equivalent	Canterbury Scientific , Ltd.	accessdata.fda.gov
January 18, 2002	K013750	ADVIA 1650 CHOLINESTERASE ASSAY	DIH	Substantially Equivalent	Bayer Diagnostics Corp.	accessdata.fda.gov
January 17, 2002	K011771	RANDOX THEOPHYLLINE	KLS	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
January 15, 2002	K011649	RANDOX VALPROIC ACID	LEG	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
January 15, 2002	K011648	RANDOX CARBAMAZEPINE	KLT	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
January 11, 2002	K012112	RANDOX DIGITOXIN	LFM	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
December 4, 2001	K011393	RANDOX PHENYTOIN	DIP	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
September 28, 2001	K011568	RANDOX LIPOPROTEIN	JIS	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
September 18, 2001	K012978	RANDOX GENTAMICIN	LCD	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
August 24, 2001	K012319	RANDOX HUMAN ASSSAYED DRUG CONTROL	DIF	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
July 2, 2001	K011303	RANDOX PHENOBARBITAL	DLZ	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
July 2, 2001	K011302	RANDOX DIGOXIN	KXT	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
May 15, 2001	K010855	RANDOX IGE	DGC	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
May 8, 2001	K010700	RANDOX MYOGLOBIN	DDR	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
March 15, 2001	K003346	RANDOX GLUCOSE (GOD/PAP)	CGA	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
February 5, 2001	K002585	RANDOX TRANSFERRIN	DDG	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
October 5, 2000	K002674	RANDOX MICROALBUMIN	DDZ	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
August 4, 2000	K001009	RANDOX C-REACTIVE PROTEIN	DCK	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
April 13, 2000	K000661	RANDOX PREALBUMIN	JZJ	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
April 5, 2000	K000375	RANDOX CALCIUM	CIC	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
April 3, 2000	K000662	RANDOX FERRITIN	DBF	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
March 27, 2000	K000469	RANDOX COMPLEMENT C3	CZW	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
March 27, 2000	K000468	RANDOX COMPLEMENT C4	DBI	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
March 23, 1999	K984494	RANDOX ALBUMIN	CIX	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
September 11, 1998	K982529	RANDOX DIRECT LDL CHOLESTEROL	MRR	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
July 30, 1998	K982341	DIRECT HDL-CHOLESTROL LIQUID	LBS	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
March 6, 1998	K973993	RANDOX CREATININE	CGX	Substantially Equivalent	Randox 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.