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Randox Laboratories, Ltd.

116 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ConcizuTrace™ ELISA (DEN240035)Randox Laboratories, Ltd.2025-05-22
ISE Electrodes (K230890)Randox Laboratories, Ltd.2023-09-08
Randox Calcium (Ca) (K182042)Randox Laboratories, Ltd.2018-10-23
Randox RX Daytona Plus Magnesium (MG) (K162200)Randox Laboratories, Ltd.2017-04-28
Liquid CO2-2 (LCO2-2) (K152085)Randox Laboratories, Ltd.2016-02-24
Direct HDL Cholesterol (HDL) (K153435)Randox Laboratories, Ltd.2016-01-08
Cholesterol (K150654)Randox Laboratories, Ltd.2015-09-29
RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT (K131554)Randox Laboratories, Ltd.2014-01-09
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR (K123977)Randox Laboratories, Ltd.2013-11-21
RANDOX CSF CONTROLS LEVELS 2 AND 3 (K132156)Randox Laboratories, Ltd.2013-10-23
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 (K132090)Randox Laboratories, Ltd.2013-08-08
HBA1C CONTROL, LEVEL 1 AND LEVEL 2 (K131999)Randox Laboratories, Ltd.2013-07-26
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 (K131776)Randox Laboratories, Ltd.2013-07-18
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 (K121603)Randox Laboratories, Ltd.2012-11-20
RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 (K113720)Randox Laboratories, Ltd.2012-09-20
RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) (K121746)Randox Laboratories, Ltd.2012-07-11
RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 (K121588)Randox Laboratories, Ltd.2012-06-20
RANDOX COCAINE METABOLITE (K113751)Randox Laboratories, Ltd.2012-05-08
RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL (K112337)Randox Laboratories, Ltd.2011-12-01
RANDOX DIGOXIN ASSAY (K102346)Randox Laboratories, Ltd.2011-10-14
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 (K110904)Randox Laboratories, Ltd.2011-09-30
RANDOX BARITURATES ASSAY (K092268)Randox Laboratories, Ltd.2011-05-25
RANDOX METHAMPHETAMINE ASSAY (K092266)Randox Laboratories, Ltd.2011-05-09
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET (K092269)Randox Laboratories, Ltd.2011-04-08
RANDOX ECSTASY (MDMA) ASSAY (K092275)Randox Laboratories, Ltd.2011-03-01
RANDOX METHADONE ASSAY (K092272)Randox Laboratories, Ltd.2010-11-18
RANDOX METABOLITE (EDDP) ASSAY (K092258)Randox Laboratories, Ltd.2010-11-09
RANDOX ETHANOL ASSAY (K092273)Randox Laboratories, Ltd.2010-11-01
RANDOX BENZODIAZEPINE ASSAY (K092274)Randox Laboratories, Ltd.2010-10-15
RANDOX LIQUID PROTEIN CALIBRATOR (K061056)Randox Laboratories, Ltd.2006-07-20
RX IMOLA (K052914)Randox Laboratories, Ltd.2006-03-31
RANDOX CALIBRATION SERUM (K053153)Randox Laboratories, Ltd.2006-01-13
RANDOX BENZODIAZEPINE CLASS ASSAY (K050179)Randox Laboratories, Ltd.2005-05-17
SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 (K043268)Randox Laboratories, Ltd.2005-02-15
RANDOX URINE CONTROLS (K043266)Randox Laboratories, Ltd.2005-02-15
POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 (K043267)Randox Laboratories, Ltd.2005-02-10
RANDOX PHENCYCLIDINE ASSAY (K043071)Randox Laboratories, Ltd.2005-01-27
RANDOX CANNABINOIDS ASSSAY (K041142)Randox Laboratories, Ltd.2004-11-23
RANDOX BARBITURATE ASSAY (K041143)Randox Laboratories, Ltd.2004-11-05
RANDOX OPIATES ASSAY (K041144)Randox Laboratories, Ltd.2004-11-03
RANDOX IMMUNOASSAY CONTROL (K040379)Randox Laboratories, Ltd.2004-06-16
RANDOX AMIKACIN (K033884)Randox Laboratories, Ltd.2004-06-09
RANDOX AMPHETAMINE CLASS ASSAY (K040350)Randox Laboratories, Ltd.2004-05-12
RANDOX METHADONE ASSAY (K040570)Randox Laboratories, Ltd.2004-05-10
RANDOX LIQUID CRP CONTROLS (K040351)Randox Laboratories, Ltd.2004-03-12
RANDOX URIC ACID (K033278)Randox Laboratories, Ltd.2004-02-27
RANDOX EVIDENCE (K030360)Randox Laboratories, Ltd.2003-12-23
RANDOX RX DAYTONA (K024014)Randox Laboratories, Ltd.2003-12-04
RANDOX LIQUID PROTEIN CALIBRATOR (K031608)Randox Laboratories, Ltd.2003-08-08
RANDOX AMMONIA (K030873)Randox Laboratories, Ltd.2003-05-12
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS (K023763)Randox Laboratories, Ltd.2003-01-13
RANDOX HAEMOGLOBIN A1C (K021897)Randox Laboratories, Ltd.2002-11-26
RANDOX C-REACTIVE PROTEIN CALIBRATOR (K022682)Randox Laboratories, Ltd.2002-11-05
RANDOX APOLIPOPROTEIN CALIBRATOR (K023158)Randox Laboratories, Ltd.2002-10-24
RANDOX LIPID CONTROL (K022591)Randox Laboratories, Ltd.2002-08-30
RANDOX THEOPHYLLINE (K011771)Randox Laboratories, Ltd.2002-01-17
RANDOX CARBAMAZEPINE (K011648)Randox Laboratories, Ltd.2002-01-15
RANDOX VALPROIC ACID (K011649)Randox Laboratories, Ltd.2002-01-15
RANDOX DIGITOXIN (K012112)Randox Laboratories, Ltd.2002-01-11
RANDOX PHENYTOIN (K011393)Randox Laboratories, Ltd.2001-12-04
RANDOX LIPOPROTEIN (K011568)Randox Laboratories, Ltd.2001-09-28
RANDOX GENTAMICIN (K012978)Randox Laboratories, Ltd.2001-09-18
RANDOX THERAPEUTIC DRUG CALIBRATOR (K012318)Randox Laboratories, Ltd.2001-09-12
RANDOX HUMAN ASSSAYED DRUG CONTROL (K012319)Randox Laboratories, Ltd.2001-08-24
RANDOX DIGOXIN (K011302)Randox Laboratories, Ltd.2001-07-02
RANDOX PHENOBARBITAL (K011303)Randox Laboratories, Ltd.2001-07-02
RANDOX IGE (K010855)Randox Laboratories, Ltd.2001-05-15
RANDOX MYOGLOBIN (K010700)Randox Laboratories, Ltd.2001-05-08
RANDOX GLUCOSE (GOD/PAP) (K003346)Randox Laboratories, Ltd.2001-03-15
RANDOX TRANSFERRIN (K002585)Randox Laboratories, Ltd.2001-02-05
RANDOX MICROALBUMIN (K002674)Randox Laboratories, Ltd.2000-10-05
RANDOX C-REACTIVE PROTEIN (K001009)Randox Laboratories, Ltd.2000-08-04
RANDOX PREALBUMIN (K000661)Randox Laboratories, Ltd.2000-04-13
RANDOX CALCIUM (K000375)Randox Laboratories, Ltd.2000-04-05
RANDOX FERRITIN (K000662)Randox Laboratories, Ltd.2000-04-03
RANDOX ALBUMIN (K000483)Randox Laboratories, Ltd.2000-03-31
RANDOX COMPLEMENT C3 (K000469)Randox Laboratories, Ltd.2000-03-27
RANDOX COMPLEMENT C4 (K000468)Randox Laboratories, Ltd.2000-03-27
RANDOX ALBUMIN (K984494)Randox Laboratories, Ltd.1999-03-23
RANDOX DIRECT LDL CHOLESTEROL (K982529)Randox Laboratories, Ltd.1998-09-11
DIRECT HDL-CHOLESTROL LIQUID (K982341)Randox Laboratories, Ltd.1998-07-30
RANDOX CREATININE (K973993)Randox Laboratories, Ltd.1998-03-06
RANDOX MAGNESIUM (K974606)Randox Laboratories, Ltd.1998-02-12
RANDOX CALCIUM (K974607)Randox Laboratories, Ltd.1998-02-02
RANDOX INORGANIC PHOSPHOROUS (K974605)Randox Laboratories, Ltd.1998-01-09
RANDOX IRON (K974604)Randox Laboratories, Ltd.1998-01-06
RANDOX BILIRUBIN (K973995)Randox Laboratories, Ltd.1997-12-08
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT (K972220)Randox Laboratories, Ltd.1997-09-09
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL (K972608)Randox Laboratories, Ltd.1997-08-04
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST (K971825)Randox Laboratories, Ltd.1997-07-24
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL (K970735)Randox Laboratories, Ltd.1997-06-06
LACTATE DEHYDROGENASE (LD) (K970684)Randox Laboratories, Ltd.1997-05-07
GLUCOSE (HEXOKINASE) KIT (K953210)Randox Laboratories, Ltd.1996-10-25
RHEUMATOID FACTOR LATEX SLIDE TEST KIT (K961169)Randox Laboratories, Ltd.1996-06-26
CALIBRATION SERUM LEVEL 1 & 2 (K955489)Randox Laboratories, Ltd.1996-06-21
AMYLASE (ETHYLIDENE PNGPG7) KIT (K953211)Randox Laboratories, Ltd.1996-06-21
TOTAL PROTEIN (URINE) (K951222)Randox Laboratories, Ltd.1996-04-24
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR (K955794)Randox Laboratories, Ltd.1996-04-05
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR (K955798)Randox Laboratories, Ltd.1996-04-05
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR (K955797)Randox Laboratories, Ltd.1996-04-05
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