Medical Device Manufacturer · IR , Antrim, N. Ireland

Randox Laboratories, Ltd. - FDA 510(k) Cleared Devices

116 submissions · 115 cleared · Since 1992
116
Total
115
Cleared
1
Denied

FDA 510(k) cleared devices by Randox Laboratories, Ltd. Toxicology

22 devices
1-22 of 22
Cleared Aug 08, 2013
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND...
K132090 · DLJ
Toxicology · 27d
Cleared May 25, 2011
RANDOX BARITURATES ASSAY
K092268 · DIS
Toxicology · 666d
Cleared May 09, 2011
RANDOX METHAMPHETAMINE ASSAY
K092266 · DKB
Toxicology · 650d
Cleared Apr 08, 2011
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
K092269 · LDJ
Toxicology · 619d
Cleared Nov 18, 2010
RANDOX METHADONE ASSAY
K092272 · DJR
Toxicology · 478d
Cleared Nov 09, 2010
RANDOX METABOLITE (EDDP) ASSAY
K092258 · DJR
Toxicology · 469d
Cleared Nov 01, 2010
RANDOX ETHANOL ASSAY
K092273 · DIC
Toxicology · 461d
Cleared Oct 15, 2010
RANDOX BENZODIAZEPINE ASSAY
K092274 · JXM
Toxicology · 444d
Cleared May 17, 2005
RANDOX BENZODIAZEPINE CLASS ASSAY
K050179 · JXM
Toxicology · 111d
Cleared Nov 23, 2004
RANDOX CANNABINOIDS ASSSAY
K041142 · LDJ
Toxicology · 207d
Cleared Nov 05, 2004
RANDOX BARBITURATE ASSAY
K041143 · DIS
Toxicology · 189d
Cleared Nov 03, 2004
RANDOX OPIATES ASSAY
K041144 · DJG
Toxicology · 187d
Cleared May 12, 2004
RANDOX AMPHETAMINE CLASS ASSAY
K040350 · DKZ
Toxicology · 90d
Cleared May 10, 2004
RANDOX METHADONE ASSAY
K040570 · DJR
Toxicology · 67d
Cleared Jan 15, 2002
RANDOX CARBAMAZEPINE
K011648 · KLT
Toxicology · 231d
Cleared Jan 15, 2002
RANDOX VALPROIC ACID
K011649 · LEG
Toxicology · 231d
Cleared Jan 11, 2002
RANDOX DIGITOXIN
K012112 · LFM
Toxicology · 189d
Cleared Dec 04, 2001
RANDOX PHENYTOIN
K011393 · DIP
Toxicology · 211d
Cleared Sep 18, 2001
RANDOX GENTAMICIN
K012978 · LCD
Toxicology · 74d
Cleared Sep 12, 2001
RANDOX THERAPEUTIC DRUG CALIBRATOR
K012318 · DKB
Toxicology · 51d
Cleared Jul 02, 2001
RANDOX DIGOXIN
K011302 · KXT
Toxicology · 63d
Cleared Jul 02, 2001
RANDOX PHENOBARBITAL
K011303 · DLZ
Toxicology · 63d
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