Randox Laboratories, Ltd. - FDA 510(k) Cleared Devices
116
Total
115
Cleared
1
Denied
116 devices
Cleared
Jan 13, 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
Chemistry
66d
Cleared
Nov 26, 2002
RANDOX HAEMOGLOBIN A1C
Chemistry
169d
Cleared
Nov 05, 2002
RANDOX C-REACTIVE PROTEIN CALIBRATOR
Chemistry
85d
Cleared
Oct 24, 2002
RANDOX APOLIPOPROTEIN CALIBRATOR
Chemistry
31d
Cleared
Aug 30, 2002
RANDOX LIPID CONTROL
Chemistry
25d
Cleared
Jan 17, 2002
RANDOX THEOPHYLLINE
Chemistry
225d
Cleared
Jan 15, 2002
RANDOX CARBAMAZEPINE
Toxicology
231d
Cleared
Jan 15, 2002
RANDOX VALPROIC ACID
Toxicology
231d
Cleared
Jan 11, 2002
RANDOX DIGITOXIN
Toxicology
189d
Cleared
Dec 04, 2001
RANDOX PHENYTOIN
Toxicology
211d
Cleared
Sep 28, 2001
RANDOX LIPOPROTEIN
Chemistry
130d
Cleared
Sep 18, 2001
RANDOX GENTAMICIN
Toxicology
74d
Cleared
Sep 12, 2001
RANDOX THERAPEUTIC DRUG CALIBRATOR
Toxicology
51d
Cleared
Aug 24, 2001
RANDOX HUMAN ASSSAYED DRUG CONTROL
Chemistry
32d
Cleared
Jul 02, 2001
RANDOX DIGOXIN
Toxicology
63d
Cleared
Jul 02, 2001
RANDOX PHENOBARBITAL
Toxicology
63d
Cleared
May 15, 2001
RANDOX IGE
Immunology
54d
Cleared
May 08, 2001
RANDOX MYOGLOBIN
Chemistry
61d
Cleared
Mar 15, 2001
RANDOX GLUCOSE (GOD/PAP)
Chemistry
141d
Cleared
Feb 05, 2001
RANDOX TRANSFERRIN
Chemistry
168d
Cleared
Oct 05, 2000
RANDOX MICROALBUMIN
Chemistry
38d
Cleared
Aug 04, 2000
RANDOX C-REACTIVE PROTEIN
Immunology
128d
Cleared
Apr 13, 2000
RANDOX PREALBUMIN
Immunology
45d
Cleared
Apr 05, 2000
RANDOX CALCIUM
Chemistry
58d
Cleared
Apr 03, 2000
RANDOX FERRITIN
Immunology
35d
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