FDA 510(k) Applications Submitted by Pauline Armstrong

FDA 510(k) Number Submission Date Device Name Applicant
K050179 01/26/2005 RANDOX BENZODIAZEPINE CLASS ASSAY RANDOX LABORATORIES, LTD.
K030360 02/03/2003 RANDOX EVIDENCE RANDOX LABORATORIES, LTD.
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
K040570 03/04/2004 RANDOX METHADONE ASSAY RANDOX LABORATORIES, LTD.
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
K150654 03/13/2015 Cholesterol RANDOX LABORATORIES, LTD.
K010855 03/22/2001 RANDOX IGE RANDOX LABORATORIES, LTD.
K150819 03/27/2015 Triglycerides Randox Laboratories Limited
K110846 03/28/2011 RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 RANDOX LABORATORIES LIMITED
K110904 03/31/2011 RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 RANDOX LABORATORIES, LTD.
K121603 04/06/2012 RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 RANDOX LABORATORIES, LTD.
K140971 04/16/2014 LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. RANDOX LABORATORIES LIMITED
K061056 04/17/2006 RANDOX LIQUID PROTEIN CALIBRATOR RANDOX LABORATORIES, LTD.
K011302 04/30/2001 RANDOX DIGOXIN RANDOX LABORATORIES, LTD.
K011303 04/30/2001 RANDOX PHENOBARBITAL RANDOX LABORATORIES, LTD.
K041361 05/21/2004 RANDOX TRI LEVEL CARDIAC CONTROL RANDOX LABORATORIES LIMITED
K011648 05/29/2001 RANDOX CARBAMAZEPINE RANDOX LABORATORIES, LTD.
K011649 05/29/2001 RANDOX VALPROIC ACID RANDOX LABORATORIES, LTD.
K131554 05/30/2013 RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT RANDOX LABORATORIES, LTD.
K121588 05/31/2012 RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 RANDOX LABORATORIES, LTD.
K121746 06/14/2012 RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) RANDOX LABORATORIES, LTD.
K131776 06/17/2013 ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 RANDOX LABORATORIES, LTD.
K161691 06/20/2016 Direct LDL Cholesterol (LDL) RANDOX LABORATORIES LIMITED
K131999 06/28/2013 HBA1C CONTROL, LEVEL 1 AND LEVEL 2 RANDOX LABORATORIES, LTD.
K012112 07/06/2001 RANDOX DIGITOXIN RANDOX LABORATORIES, LTD.
K012978 07/06/2001 RANDOX GENTAMICIN RANDOX LABORATORIES, LTD.
K132156 07/11/2013 RANDOX CSF CONTROLS LEVELS 2 AND 3 RANDOX LABORATORIES, LTD.
K132090 07/12/2013 BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 RANDOX LABORATORIES, LTD.
K122126 07/18/2012 DIRECT LDL/HDL CHOLESTEROL CALIBRATOR RANDOX LABORATORIES LIMITED
K152085 07/27/2015 Liquid CO2-2 (LCO2-2) RANDOX LABORATORIES LTD
K092272 07/28/2009 RANDOX METHADONE ASSAY RANDOX LABORATORIES, LTD.
K092274 07/28/2009 RANDOX BENZODIAZEPINE ASSAY RANDOX LABORATORIES, LTD.
K182042 07/30/2018 Randox Calcium (Ca) Randox Laboratories Ltd.
K022591 08/05/2002 RANDOX LIPID CONTROL RANDOX LABORATORIES, LTD.
K142181 08/08/2014 RANDOX ALDOLASE CALIBRATION SERUM RANDOX LABORATORIES LIMITED
K022682 08/12/2002 RANDOX C-REACTIVE PROTEIN CALIBRATOR RANDOX LABORATORIES, LTD.
K162275 08/12/2016 Randox RX Daytona Plus Alkaline Phosphatase (ALP) RANDOX LABORATORIES LIMITED
K112337 08/15/2011 RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL RANDOX LABORATORIES, LTD.
K102346 08/19/2010 RANDOX DIGOXIN ASSAY RANDOX LABORATORIES, LTD.
K152344 08/19/2015 Total Bilirubin RANDOX LABORATORIES LIMITED
K152343 08/19/2015 Direct Bilirubin RANDOX LABORATORIES LIMITED
K002585 08/21/2000 RANDOX TRANSFERRIN RANDOX LABORATORIES, LTD.
K002674 08/28/2000 RANDOX MICROALBUMIN RANDOX LABORATORIES, LTD.
K023158 09/23/2002 RANDOX APOLIPOPROTEIN CALIBRATOR RANDOX LABORATORIES, LTD.
K052914 10/14/2005 RX IMOLA RANDOX LABORATORIES, LTD.
K053153 11/10/2005 RANDOX CALIBRATION SERUM RANDOX LABORATORIES, LTD.
K153435 11/27/2015 Direct HDL Cholesterol (HDL) Randox Laboratories Ltd
K033884 12/15/2003 RANDOX AMIKACIN RANDOX LABORATORIES, LTD.
K113720 12/19/2011 RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 RANDOX LABORATORIES, LTD.
K113747 12/20/2011 RANDOX OPIATES ASSAY RANDOX LABORATORIES LIMITED
K113751 12/21/2011 RANDOX COCAINE METABOLITE RANDOX LABORATORIES, LTD.
K123977 12/26/2012 RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR RANDOX LABORATORIES, LTD.
K162200 08/05/2016 Randox RX Daytona Plus Magnesium (MG) RANDOX LABORATORIES LTD


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