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

Cleared Sep 08, 2023

ISE Electrodes

K230890 · CEM

Chemistry · 161d

Cleared Oct 23, 2018

Randox Calcium (Ca)

K182042 · CJY

Chemistry · 85d

Cleared Apr 28, 2017

Randox RX Daytona Plus Magnesium (MG)

K162200 · JGJ

Chemistry · 266d

Cleared Feb 24, 2016

Liquid CO2-2 (LCO2-2)

K152085 · KHS

Chemistry · 212d

Cleared Jan 08, 2016

Direct HDL Cholesterol (HDL)

K153435 · LBS

Chemistry · 42d

Cleared Sep 29, 2015

Cholesterol

K150654 · CHH

Chemistry · 200d

Cleared Jan 09, 2014

RX DAYTONA PLUS CHEMISTRY ANALYZER

K131554 · JJE

Chemistry · 224d

Cleared Nov 21, 2013

RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

K123977 · CGS

Chemistry · 330d

Cleared Oct 23, 2013

RANDOX CSF CONTROLS LEVELS 2 AND 3

K132156 · JJY

Chemistry · 104d

Cleared Jul 26, 2013

HBA1C CONTROL, LEVEL 1 AND LEVEL 2

K131999 · JJX

Chemistry · 28d

Cleared Jul 18, 2013

ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3

K131776 · JJX

Chemistry · 31d

Cleared Nov 20, 2012

RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3

K121603 · JJY

Chemistry · 228d