FDA 510(k) Applications Submitted by RANDOX LABORATORIES, LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K951222 03/20/1995 TOTAL PROTEIN (URINE) RANDOX LABORATORIES, LTD.
K951221 03/20/1995 TOTAL CO2 RANDOX LABORATORIES, LTD.
K953211 07/10/1995 AMYLASE (ETHYLIDENE PNGPG7) KIT RANDOX LABORATORIES, LTD.
K953210 07/10/1995 GLUCOSE (HEXOKINASE) KIT RANDOX LABORATORIES, LTD.
K955489 11/27/1995 CALIBRATION SERUM LEVEL 1 & 2 RANDOX LABORATORIES, LTD.
K955797 12/22/1995 IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR RANDOX LABORATORIES, LTD.
K955798 12/22/1995 IGG IMMUNOTURBIDIMETRIC & CALIBRATOR RANDOX LABORATORIES, LTD.
K955794 12/22/1995 IGA IMMUNOTURBIDIMETRIC & CALIBRATOR RANDOX LABORATORIES, LTD.
K030873 03/20/2003 RANDOX AMMONIA RANDOX LABORATORIES, LTD.
K033278 10/10/2003 RANDOX URIC ACID RANDOX LABORATORIES, LTD.
K023763 11/08/2002 RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS RANDOX LABORATORIES, LTD.
K024014 12/04/2002 RANDOX RX DAYTONA RANDOX LABORATORIES, LTD.
K000468 02/11/2000 RANDOX COMPLEMENT C4 RANDOX LABORATORIES, LTD.
K000483 02/14/2000 RANDOX ALBUMIN RANDOX LABORATORIES, LTD.
K000661 02/28/2000 RANDOX PREALBUMIN RANDOX LABORATORIES, LTD.
K011568 05/21/2001 RANDOX LIPOPROTEIN RANDOX LABORATORIES, LTD.
K011771 06/06/2001 RANDOX THEOPHYLLINE RANDOX LABORATORIES, LTD.
K021897 06/10/2002 RANDOX HAEMOGLOBIN A1C RANDOX LABORATORIES, LTD.
K982341 06/22/1998 DIRECT HDL-CHOLESTROL LIQUID RANDOX LABORATORIES, LTD.
K982529 07/20/1998 RANDOX DIRECT LDL CHOLESTEROL RANDOX LABORATORIES, LTD.
K012318 07/23/2001 RANDOX THERAPEUTIC DRUG CALIBRATOR RANDOX LABORATORIES, LTD.
K092266 07/28/2009 RANDOX METHAMPHETAMINE ASSAY RANDOX LABORATORIES, LTD.
K092269 07/28/2009 CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET RANDOX LABORATORIES, LTD.
K092268 07/28/2009 RANDOX BARITURATES ASSAY RANDOX LABORATORIES, LTD.
K973993 10/21/1997 RANDOX CREATININE RANDOX LABORATORIES, LTD.
K973995 10/21/1997 RANDOX BILIRUBIN RANDOX LABORATORIES, LTD.
K043268 11/26/2004 SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 RANDOX LABORATORIES, LTD.
K974604 12/10/1997 RANDOX IRON RANDOX LABORATORIES, LTD.
K984494 12/17/1998 RANDOX ALBUMIN RANDOX LABORATORIES, LTD.
K970735 02/18/1997 BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL RANDOX LABORATORIES, LTD.
K010700 03/08/2001 RANDOX MYOGLOBIN RANDOX LABORATORIES, LTD.
K000375 02/07/2000 RANDOX CALCIUM RANDOX LABORATORIES, LTD.
K040350 02/12/2004 RANDOX AMPHETAMINE CLASS ASSAY RANDOX LABORATORIES, LTD.
K040351 02/12/2004 RANDOX LIQUID CRP CONTROLS RANDOX LABORATORIES, LTD.
K040379 02/17/2004 RANDOX IMMUNOASSAY CONTROL RANDOX LABORATORIES, LTD.
K000662 02/28/2000 RANDOX FERRITIN RANDOX LABORATORIES, LTD.
K961169 03/25/1996 RHEUMATOID FACTOR LATEX SLIDE TEST KIT RANDOX LABORATORIES, LTD.
K001009 03/29/2000 RANDOX C-REACTIVE PROTEIN RANDOX LABORATORIES, LTD.
K041142 04/30/2004 RANDOX CANNABINOIDS ASSSAY RANDOX LABORATORIES, LTD.
K041143 04/30/2004 RANDOX BARBITURATE ASSAY RANDOX LABORATORIES, LTD.
K041144 04/30/2004 RANDOX OPIATES ASSAY RANDOX LABORATORIES, LTD.
K011393 05/07/2001 RANDOX PHENYTOIN RANDOX LABORATORIES, LTD.
K031608 05/22/2003 RANDOX LIQUID PROTEIN CALIBRATOR RANDOX LABORATORIES, LTD.
K972608 06/11/1997 RANDOX ASSAYED SPECIFIC PROTEIN CONTROL RANDOX LABORATORIES, LTD.
K972220 06/12/1997 RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT RANDOX LABORATORIES, LTD.
K012319 07/23/2001 RANDOX HUMAN ASSSAYED DRUG CONTROL RANDOX LABORATORIES, LTD.
K092275 07/28/2009 RANDOX ECSTASY (MDMA) ASSAY RANDOX LABORATORIES, LTD.
K092273 07/28/2009 RANDOX ETHANOL ASSAY RANDOX LABORATORIES, LTD.
K092258 07/28/2009 RANDOX METABOLITE (EDDP) ASSAY RANDOX LABORATORIES, LTD.
K003346 10/25/2000 RANDOX GLUCOSE (GOD/PAP) RANDOX LABORATORIES, LTD.
K043071 11/08/2004 RANDOX PHENCYCLIDINE ASSAY RANDOX LABORATORIES, LTD.
K043267 11/26/2004 POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 RANDOX LABORATORIES, LTD.
K043266 11/26/2004 RANDOX URINE CONTROLS RANDOX LABORATORIES, LTD.
K974605 12/10/1997 RANDOX INORGANIC PHOSPHOROUS RANDOX LABORATORIES, LTD.
K974606 12/10/1997 RANDOX MAGNESIUM RANDOX LABORATORIES, LTD.
K974607 12/10/1997 RANDOX CALCIUM RANDOX LABORATORIES, LTD.
K050179 01/26/2005 RANDOX BENZODIAZEPINE CLASS ASSAY RANDOX LABORATORIES, LTD.
K030360 02/03/2003 RANDOX EVIDENCE RANDOX LABORATORIES, LTD.
K040570 03/04/2004 RANDOX METHADONE ASSAY RANDOX LABORATORIES, LTD.
K150654 03/13/2015 Cholesterol RANDOX LABORATORIES, LTD.
K010855 03/22/2001 RANDOX IGE RANDOX LABORATORIES, LTD.
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.
K061056 04/17/2006 RANDOX LIQUID PROTEIN CALIBRATOR RANDOX LABORATORIES, LTD.
K011303 04/30/2001 RANDOX PHENOBARBITAL RANDOX LABORATORIES, LTD.
K011302 04/30/2001 RANDOX DIGOXIN RANDOX LABORATORIES, LTD.
K011649 05/29/2001 RANDOX VALPROIC ACID RANDOX LABORATORIES, LTD.
K011648 05/29/2001 RANDOX CARBAMAZEPINE 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.
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.
K092272 07/28/2009 RANDOX METHADONE ASSAY RANDOX LABORATORIES, LTD.
K092274 07/28/2009 RANDOX BENZODIAZEPINE ASSAY RANDOX LABORATORIES, LTD.
K022591 08/05/2002 RANDOX LIPID CONTROL RANDOX LABORATORIES, LTD.
K022682 08/12/2002 RANDOX C-REACTIVE PROTEIN CALIBRATOR RANDOX LABORATORIES, LTD.
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.
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.
K033884 12/15/2003 RANDOX AMIKACIN RANDOX LABORATORIES, LTD.
K113720 12/19/2011 RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 RANDOX LABORATORIES, LTD.
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.
K970684 02/24/1997 LACTATE DEHYDROGENASE (LD) RANDOX LABORATORIES, LTD.
K971825 05/16/1997 PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST RANDOX LABORATORIES, LTD.
K000469 02/11/2000 RANDOX COMPLEMENT C3 RANDOX LABORATORIES, LTD.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact