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
78 devices
26-50 of 78
Cleared Jan 27, 2005
RANDOX PHENCYCLIDINE ASSAY
K043071 · LCM
Chemistry · 80d
Cleared Jun 16, 2004
RANDOX IMMUNOASSAY CONTROL
K040379 · JJY
Chemistry · 120d
Cleared Jun 09, 2004
RANDOX AMIKACIN
K033884 · KLQ
Chemistry · 177d
Cleared Mar 12, 2004
RANDOX LIQUID CRP CONTROLS
K040351 · JJX
Chemistry · 29d
Cleared Feb 27, 2004
RANDOX URIC ACID
K033278 · CDO
Chemistry · 140d
Cleared Dec 23, 2003
RANDOX EVIDENCE
K030360 · DIO
Chemistry · 323d
Cleared Dec 04, 2003
RANDOX RX DAYTONA
K024014 · CGA
Chemistry · 365d
Cleared Aug 08, 2003
RANDOX LIQUID PROTEIN CALIBRATOR
K031608 · JIX
Chemistry · 78d
Cleared May 12, 2003
RANDOX AMMONIA
K030873 · JIF
Chemistry · 53d
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 Sep 28, 2001
RANDOX LIPOPROTEIN
K011568 · JIS
Chemistry · 130d
Cleared Aug 24, 2001
RANDOX HUMAN ASSSAYED DRUG CONTROL
K012319 · DIF
Chemistry · 32d
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 Apr 05, 2000
RANDOX CALCIUM
K000375 · CIC
Chemistry · 58d
Cleared Mar 31, 2000
RANDOX ALBUMIN
K000483 · CJW
Chemistry · 46d
Cleared Mar 23, 1999
RANDOX ALBUMIN
K984494 · CIX
Chemistry · 96d
Cleared Sep 11, 1998
RANDOX DIRECT LDL CHOLESTEROL
K982529 · MRR
Chemistry · 53d

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