Randox Laboratories, Ltd. - FDA 510(k) Cleared Devices
116
Total
115
Cleared
1
Denied
116 devices
Cleared
Mar 31, 2000
RANDOX ALBUMIN
Chemistry
46d
Cleared
Mar 27, 2000
RANDOX COMPLEMENT C4
Immunology
45d
Cleared
Mar 27, 2000
RANDOX COMPLEMENT C3
Immunology
45d
Cleared
Mar 23, 1999
RANDOX ALBUMIN
Chemistry
96d
Cleared
Sep 11, 1998
RANDOX DIRECT LDL CHOLESTEROL
Chemistry
53d
Cleared
Jul 30, 1998
DIRECT HDL-CHOLESTROL LIQUID
Chemistry
38d
Cleared
Mar 06, 1998
RANDOX CREATININE
Chemistry
136d
Cleared
Feb 12, 1998
RANDOX MAGNESIUM
Chemistry
64d
Cleared
Feb 02, 1998
RANDOX CALCIUM
Chemistry
54d
Cleared
Jan 09, 1998
RANDOX INORGANIC PHOSPHOROUS
Chemistry
30d
Cleared
Jan 06, 1998
RANDOX IRON
Chemistry
27d
Cleared
Dec 08, 1997
RANDOX BILIRUBIN
Chemistry
48d
Cleared
Sep 09, 1997
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
Immunology
89d
Cleared
Aug 04, 1997
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
Immunology
54d
Cleared
Jul 24, 1997
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
Chemistry
69d
Cleared
Jun 06, 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
Chemistry
108d
Cleared
May 07, 1997
LACTATE DEHYDROGENASE (LD)
Chemistry
72d
Cleared
Oct 25, 1996
GLUCOSE (HEXOKINASE) KIT
Chemistry
473d
Cleared
Jun 26, 1996
RHEUMATOID FACTOR LATEX SLIDE TEST KIT
Immunology
93d
Cleared
Jun 21, 1996
AMYLASE (ETHYLIDENE PNGPG7) KIT
Chemistry
347d
Cleared
Jun 21, 1996
CALIBRATION SERUM LEVEL 1 & 2
Chemistry
207d
Cleared
Apr 24, 1996
TOTAL PROTEIN (URINE)
Chemistry
401d
Cleared
Apr 05, 1996
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
Immunology
105d
Cleared
Apr 05, 1996
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
Immunology
105d
Cleared
Apr 05, 1996
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR
Immunology
105d
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