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
116 devices
51-75 of 116
Cleared Jan 13, 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763 · LCP
Chemistry · 66d
Cleared Nov 26, 2002
RANDOX HAEMOGLOBIN A1C
K021897 · LCP
Chemistry · 169d
Cleared Nov 05, 2002
RANDOX C-REACTIVE PROTEIN CALIBRATOR
K022682 · JIS
Chemistry · 85d
Cleared Oct 24, 2002
RANDOX APOLIPOPROTEIN CALIBRATOR
K023158 · JIX
Chemistry · 31d
Cleared Aug 30, 2002
RANDOX LIPID CONTROL
K022591 · JJY
Chemistry · 25d
Cleared Jan 17, 2002
RANDOX THEOPHYLLINE
K011771 · KLS
Chemistry · 225d
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 28, 2001
RANDOX LIPOPROTEIN
K011568 · JIS
Chemistry · 130d
Cleared Sep 18, 2001
RANDOX GENTAMICIN
K012978 · LCD
Toxicology · 74d
Cleared Sep 12, 2001
RANDOX THERAPEUTIC DRUG CALIBRATOR
K012318 · DKB
Toxicology · 51d
Cleared Aug 24, 2001
RANDOX HUMAN ASSSAYED DRUG CONTROL
K012319 · DIF
Chemistry · 32d
Cleared Jul 02, 2001
RANDOX DIGOXIN
K011302 · KXT
Toxicology · 63d
Cleared Jul 02, 2001
RANDOX PHENOBARBITAL
K011303 · DLZ
Toxicology · 63d
Cleared May 15, 2001
RANDOX IGE
K010855 · DGC
Immunology · 54d
Cleared May 08, 2001
RANDOX MYOGLOBIN
K010700 · DDR
Chemistry · 61d
Cleared Mar 15, 2001
RANDOX GLUCOSE (GOD/PAP)
K003346 · CGA
Chemistry · 141d
Cleared Feb 05, 2001
RANDOX TRANSFERRIN
K002585 · DDG
Chemistry · 168d
Cleared Oct 05, 2000
RANDOX MICROALBUMIN
K002674 · DDZ
Chemistry · 38d
Cleared Aug 04, 2000
RANDOX C-REACTIVE PROTEIN
K001009 · DCK
Immunology · 128d
Cleared Apr 13, 2000
RANDOX PREALBUMIN
K000661 · JZJ
Immunology · 45d
Cleared Apr 05, 2000
RANDOX CALCIUM
K000375 · CIC
Chemistry · 58d
Cleared Apr 03, 2000
RANDOX FERRITIN
K000662 · DBF
Immunology · 35d

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