Randox Laboratories, Ltd. - FDA 510(k) Cleared Devices
116
Total
115
Cleared
1
Denied
Randox Laboratories, Ltd. has 115 FDA 510(k) cleared medical devices. Based in Antrim, N. Ireland, IR.
Last cleared in 2023. Active since 1992. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Randox Laboratories, Ltd. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Randox Laboratories, Ltd.
116 devices
Not Cleared
May 22, 2025
ConcizuTrace™ ELISA
Hematology
325d
Cleared
Sep 08, 2023
ISE Electrodes
Chemistry
161d
Cleared
Oct 23, 2018
Randox Calcium (Ca)
Chemistry
85d
Cleared
Apr 28, 2017
Randox RX Daytona Plus Magnesium (MG)
Chemistry
266d
Cleared
Feb 24, 2016
Liquid CO2-2 (LCO2-2)
Chemistry
212d
Cleared
Jan 08, 2016
Direct HDL Cholesterol (HDL)
Chemistry
42d
Cleared
Sep 29, 2015
Cholesterol
Chemistry
200d
Cleared
Jan 09, 2014
RX DAYTONA PLUS CHEMISTRY ANALYZER
Chemistry
224d
Cleared
Nov 21, 2013
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
Chemistry
330d
Cleared
Oct 23, 2013
RANDOX CSF CONTROLS LEVELS 2 AND 3
Chemistry
104d
Cleared
Aug 08, 2013
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND...
Toxicology
27d
Cleared
Jul 26, 2013
HBA1C CONTROL, LEVEL 1 AND LEVEL 2
Chemistry
28d
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