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Randox Laboratories, Ltd.

FDA 510(k) & PMA Approved Devices — 113 products

Total Devices113
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K230890 ISE ElectrodesCEM2023-09-08 View
510(k) K182042 Randox Calcium (Ca)CJY2018-10-23 View
510(k) K162200 Randox RX Daytona Plus Magnesium (MG)JGJ2017-04-28 View
510(k) K152085 Liquid CO2-2 (LCO2-2)KHS2016-02-24 View
510(k) K153435 Direct HDL Cholesterol (HDL)LBS2016-01-08 View
510(k) K123977 RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORCGS2013-11-21 View
510(k) K132156 RANDOX CSF CONTROLS LEVELS 2 AND 3JJY2013-10-23 View
510(k) K132090 BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2DLJ2013-08-08 View
510(k) K131999 HBA1C CONTROL, LEVEL 1 AND LEVEL 2JJX2013-07-26 View
510(k) K131776 ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3JJX2013-07-18 View
510(k) K121603 RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3JJY2012-11-20 View
510(k) K113720 RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3JJY2012-09-20 View
510(k) K121746 RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)JJX2012-07-11 View
510(k) K121588 RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3JJX2012-06-20 View
510(k) K113751 RANDOX COCAINE METABOLITEDIO2012-05-08 View
510(k) K112337 RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVELJJY2011-12-01 View
510(k) K102346 RANDOX DIGOXIN ASSAYKXT2011-10-14 View
510(k) K110904 RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3JJY2011-09-30 View
510(k) K092268 RANDOX BARITURATES ASSAYDIS2011-05-25 View
510(k) K092266 RANDOX METHAMPHETAMINE ASSAYDKB2011-05-09 View
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