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
76-100 of 116
Cleared Mar 31, 2000
RANDOX ALBUMIN
K000483 · CJW
Chemistry · 46d
Cleared Mar 27, 2000
RANDOX COMPLEMENT C4
K000468 · DBI
Immunology · 45d
Cleared Mar 27, 2000
RANDOX COMPLEMENT C3
K000469 · CZW
Immunology · 45d
Cleared Mar 23, 1999
RANDOX ALBUMIN
K984494 · CIX
Chemistry · 96d
Cleared Sep 11, 1998
RANDOX DIRECT LDL CHOLESTEROL
K982529 · MRR
Chemistry · 53d
Cleared Jul 30, 1998
DIRECT HDL-CHOLESTROL LIQUID
K982341 · LBS
Chemistry · 38d
Cleared Mar 06, 1998
RANDOX CREATININE
K973993 · CGX
Chemistry · 136d
Cleared Feb 12, 1998
RANDOX MAGNESIUM
K974606 · JGJ
Chemistry · 64d
Cleared Feb 02, 1998
RANDOX CALCIUM
K974607 · CJY
Chemistry · 54d
Cleared Jan 09, 1998
RANDOX INORGANIC PHOSPHOROUS
K974605 · CEO
Chemistry · 30d
Cleared Jan 06, 1998
RANDOX IRON
K974604 · JMO
Chemistry · 27d
Cleared Dec 08, 1997
RANDOX BILIRUBIN
K973995 · GIG
Chemistry · 48d
Cleared Sep 09, 1997
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
K972220 · DHR
Immunology · 89d
Cleared Aug 04, 1997
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
K972608 · JJY
Immunology · 54d
Cleared Jul 24, 1997
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
K971825 · JFJ
Chemistry · 69d
Cleared Jun 06, 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K970735 · LBS
Chemistry · 108d
Cleared May 07, 1997
LACTATE DEHYDROGENASE (LD)
K970684 · CFJ
Chemistry · 72d
Cleared Oct 25, 1996
GLUCOSE (HEXOKINASE) KIT
K953210 · CFR
Chemistry · 473d
Cleared Jun 26, 1996
RHEUMATOID FACTOR LATEX SLIDE TEST KIT
K961169 · DHR
Immunology · 93d
Cleared Jun 21, 1996
AMYLASE (ETHYLIDENE PNGPG7) KIT
K953211 · CIJ
Chemistry · 347d
Cleared Jun 21, 1996
CALIBRATION SERUM LEVEL 1 & 2
K955489 · JIX
Chemistry · 207d
Cleared Apr 24, 1996
TOTAL PROTEIN (URINE)
K951222 · JIR
Chemistry · 401d
Cleared Apr 05, 1996
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
K955794 · CZP
Immunology · 105d
Cleared Apr 05, 1996
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
K955797 · DFT
Immunology · 105d
Cleared Apr 05, 1996
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR
K955798 · DEW
Immunology · 105d

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