Randox Laboratories Limited - FDA 510(k) Cleared Devices

Cleared Oct 05, 2023

Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT

K220451 · DJG

Chemistry · 595d

Cleared Apr 21, 2017

Randox RX Daytona Plus Alkaline Phosphatase (ALP)

K162275 · CJE

Chemistry · 252d

Cleared Mar 20, 2017

Direct LDL Cholesterol (LDL)

K161691 · MRR

Chemistry · 273d

Cleared Feb 16, 2016

Direct Bilirubin

K152343 · JFM

Chemistry · 181d

Cleared Jan 28, 2016

Total Bilirubin

K152344 · JFM

Chemistry · 162d

Cleared Aug 06, 2015

Triglycerides

K150819 · CDT

Chemistry · 132d

Cleared Dec 08, 2014

LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.

K140971 · JJY

Chemistry · 236d

Cleared Sep 18, 2014

RANDOX ALDOLASE CALIBRATION SERUM

K142181 · JIT

Chemistry · 41d

Cleared May 22, 2014

RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND...

K140522 · JJY

Chemistry · 79d

Cleared Mar 25, 2014

RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3

K140393 · JJY

Chemistry · 39d

Cleared Aug 24, 2012

RANDOX OPIATES ASSAY

K113747 · DJG

Chemistry · 248d

Cleared Aug 14, 2012

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

K122126 · JIS

Chemistry · 27d