Randox Laboratories, Ltd. - FDA 510(k) Cleared Devices

Randox Laboratories, Ltd. is a global diagnostic company specializing in chemistry devices and laboratory solutions. The company operates with a manufacturing facility in Antrim, Northern Ireland, and has over 40 years of expertise in diagnostic innovation.

Randox has received 115 FDA 510(k) clearances from 116 total submissions since its first clearance in 1992. The company's regulatory portfolio is dominated by chemistry devices, including clinical chemistry analyzers, reagents, controls, and electrodes. The latest clearance on record dates to 2023.

Recent FDA 510(k) cleared devices include the RX Daytona Plus Chemistry Analyzer, direct HDL cholesterol and magnesium assays, CK-MB calibrators, and HbA1c controls. The company also manufactures ISE electrodes and liquid CO2 reagents for clinical laboratory use.

Explore the complete regulatory record, including device names, product codes, and clearance dates, in the 510(k) database.