Randox Laboratories Limited - FDA 510(k) Cleared Devices
18
Total
18
Cleared
0
Denied
15 devices
Cleared
Oct 05, 2023
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
Chemistry
595d
Cleared
Apr 21, 2017
Randox RX Daytona Plus Alkaline Phosphatase (ALP)
Chemistry
252d
Cleared
Mar 20, 2017
Direct LDL Cholesterol (LDL)
Chemistry
273d
Cleared
Feb 16, 2016
Direct Bilirubin
Chemistry
181d
Cleared
Jan 28, 2016
Total Bilirubin
Chemistry
162d
Cleared
Aug 06, 2015
Triglycerides
Chemistry
132d
Cleared
Dec 08, 2014
LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
Chemistry
236d
Cleared
Sep 18, 2014
RANDOX ALDOLASE CALIBRATION SERUM
Chemistry
41d
Cleared
May 22, 2014
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND...
Chemistry
79d
Cleared
Mar 25, 2014
RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
Chemistry
39d
Cleared
Aug 24, 2012
RANDOX OPIATES ASSAY
Chemistry
248d
Cleared
Aug 14, 2012
DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
Chemistry
27d
Cleared
Jan 23, 2012
RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
Chemistry
332d
Cleared
Sep 30, 2011
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
Chemistry
186d
Cleared
Sep 09, 2004
RANDOX TRI LEVEL CARDIAC CONTROL
Chemistry
111d