Randox Laboratories, Ltd. - FDA 510(k) Cleared Devices
116
Total
115
Cleared
1
Denied
78 devices
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
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 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
Feb 15, 1996
TOTAL CO2
Chemistry
332d
Cleared
Dec 26, 1995
CK-MB (NAC-ACT)
Chemistry
281d
Cleared
Sep 15, 1995
APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT
Chemistry
227d
Cleared
Sep 15, 1995
APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT
Chemistry
227d
Cleared
Mar 13, 1995
PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED
Chemistry
293d
Cleared
Jan 10, 1994
CHOLESTEROL ENZYMATIC ENDPOINT
Chemistry
544d
Cleared
Sep 27, 1993
UREA KIT
Chemistry
439d
Cleared
Jul 28, 1993
TRIGLYCERIDES GPO-PAP
Chemistry
378d
Cleared
Jul 22, 1993
URIC ACID ENZYMATIC COLORIMERIC KIT
Chemistry
372d
Cleared
Dec 03, 1992
ALKALINE PHOSPHATASE KIT
Chemistry
141d
Cleared
Dec 03, 1992
GAMMA-GT
Chemistry
141d
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