FDA 510(k) Applications Submitted by RANDOX LABORATORIES LIMITED

FDA 510(k) Number Submission Date Device Name Applicant
K130337 02/11/2013 RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 RANDOX LABORATORIES LIMITED
K140393 02/14/2014 RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 RANDOX LABORATORIES LIMITED
K110534 02/25/2011 RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 RANDOX LABORATORIES LIMITED
K140522 03/04/2014 RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL RANDOX LABORATORIES LIMITED
K150819 03/27/2015 Triglycerides Randox Laboratories Limited
K110846 03/28/2011 RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 RANDOX LABORATORIES LIMITED
K140971 04/16/2014 LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. RANDOX LABORATORIES LIMITED
K041361 05/21/2004 RANDOX TRI LEVEL CARDIAC CONTROL RANDOX LABORATORIES LIMITED
K161691 06/20/2016 Direct LDL Cholesterol (LDL) RANDOX LABORATORIES LIMITED
K122126 07/18/2012 DIRECT LDL/HDL CHOLESTEROL CALIBRATOR RANDOX LABORATORIES LIMITED
K142181 08/08/2014 RANDOX ALDOLASE CALIBRATION SERUM RANDOX LABORATORIES LIMITED
K162275 08/12/2016 Randox RX Daytona Plus Alkaline Phosphatase (ALP) RANDOX LABORATORIES LIMITED
K152343 08/19/2015 Direct Bilirubin RANDOX LABORATORIES LIMITED
K152344 08/19/2015 Total Bilirubin RANDOX LABORATORIES LIMITED
K113747 12/20/2011 RANDOX OPIATES ASSAY RANDOX LABORATORIES LIMITED


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