Randox Laboratories, Ltd. - FDA 510(k) Cleared Devices
116
Total
115
Cleared
1
Denied
78 devices
Cleared
Jan 27, 2005
RANDOX PHENCYCLIDINE ASSAY
Chemistry
80d
Cleared
Jun 16, 2004
RANDOX IMMUNOASSAY CONTROL
Chemistry
120d
Cleared
Jun 09, 2004
RANDOX AMIKACIN
Chemistry
177d
Cleared
Mar 12, 2004
RANDOX LIQUID CRP CONTROLS
Chemistry
29d
Cleared
Feb 27, 2004
RANDOX URIC ACID
Chemistry
140d
Cleared
Dec 23, 2003
RANDOX EVIDENCE
Chemistry
323d
Cleared
Dec 04, 2003
RANDOX RX DAYTONA
Chemistry
365d
Cleared
Aug 08, 2003
RANDOX LIQUID PROTEIN CALIBRATOR
Chemistry
78d
Cleared
May 12, 2003
RANDOX AMMONIA
Chemistry
53d
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
Sep 28, 2001
RANDOX LIPOPROTEIN
Chemistry
130d
Cleared
Aug 24, 2001
RANDOX HUMAN ASSSAYED DRUG CONTROL
Chemistry
32d
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
Apr 05, 2000
RANDOX CALCIUM
Chemistry
58d
Cleared
Mar 31, 2000
RANDOX ALBUMIN
Chemistry
46d
Cleared
Mar 23, 1999
RANDOX ALBUMIN
Chemistry
96d
Cleared
Sep 11, 1998
RANDOX DIRECT LDL CHOLESTEROL
Chemistry
53d
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