Medical Device Manufacturer · IR , Antrim, N. Ireland

Randox Laboratories, Ltd.

116 submissions · 115 cleared · Since 1992
116
Total
115
Cleared
1
Denied

Randox Laboratories, Ltd. — FDA 510(k) Submissions

Randox Laboratories, Ltd. has submitted 116 FDA 510(k) premarket notifications since 1992, of which 115 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Calibrator, Multi-analyte Mixture, Single (specified) Analyte Controls (assayed And Unassayed), Enzyme Immunoassay, Methadone, Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes . Use the specialty filter in the sidebar to narrow results.

116 devices
1–25 of 116
ConcizuTrace? ELISA
DEN240035 · SES Non-factor Replacement... · Hematology
May 2025 325d
ISE Electrodes
K230890 · CEM Electrode, Ion Specific,... · Chemistry
Sep 2023 161d
Randox Calcium (Ca)
K182042 · CJY Azo Dye, Calcium · Chemistry
Oct 2018 85d
Randox RX Daytona Plus Magnesium (MG)
K162200 · JGJ Photometric Method,... · Chemistry
Apr 2017 266d
Liquid CO2-2 (LCO2-2)
K152085 · KHS Enzymatic, Carbon-dioxide · Chemistry
Feb 2016 212d
Direct HDL Cholesterol (HDL)
K153435 · LBS Ldl & Vldl Precipitation,... · Chemistry
Jan 2016 42d
Cholesterol
K150654 · CHH Enzymatic... · Chemistry
Sep 2015 200d
RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
K131554 · JJE Analyzer, Chemistry... · Chemistry
Jan 2014 224d
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
K123977 · CGS Nad Reduction/nadh... · Chemistry
Nov 2013 330d
RANDOX CSF CONTROLS LEVELS 2 AND 3
K132156 · JJY Multi-analyte Controls,... · Chemistry
Oct 2013 104d
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
K132090 · DLJ Calibrators, Drug Specific · Toxicology
Aug 2013 27d
HBA1C CONTROL, LEVEL 1 AND LEVEL 2
K131999 · JJX Single (specified)... · Chemistry
Jul 2013 28d
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
K131776 · JJX Single (specified)... · Chemistry
Jul 2013 31d
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
K121603 · JJY Multi-analyte Controls,... · Chemistry
Nov 2012 228d
RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
K113720 · JJY Multi-analyte Controls,... · Chemistry
Sep 2012 276d
RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
K121746 · JJX Single (specified)... · Chemistry
Jul 2012 27d
RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
K121588 · JJX Single (specified)... · Chemistry
Jun 2012 20d
RANDOX COCAINE METABOLITE
K113751 · DIO Enzyme Immunoassay,... · Chemistry
May 2012 139d
RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
K112337 · JJY Multi-analyte Controls,... · Chemistry
Dec 2011 108d
RANDOX DIGOXIN ASSAY
K102346 · KXT Enzyme Immunoassay, Digoxin · Chemistry
Oct 2011 421d
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
K110904 · JJY Multi-analyte Controls,... · Chemistry
Sep 2011 183d
RANDOX BARITURATES ASSAY
K092268 · DIS Enzyme Immunoassay,... · Toxicology
May 2011 666d
RANDOX METHAMPHETAMINE ASSAY
K092266 · DKB Calibrators, Drug Mixture · Toxicology
May 2011 650d
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
K092269 · LDJ Enzyme Immunoassay,... · Toxicology
Apr 2011 619d
RANDOX ECSTASY (MDMA) ASSAY
K092275 · DKZ Enzyme Immunoassay,... · Chemistry
Mar 2011 581d

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