Wako Chemicals USA, Inc. - FDA 510(k) Cleared Devices
124
Total
123
Cleared
1
Denied
124 devices
Cleared
May 07, 1997
WAKO DIRECT BILIRUBIN V
Chemistry
50d
Cleared
Apr 21, 1997
WAKO TOTAL BILIRUBIN V
Chemistry
34d
Cleared
Dec 24, 1996
WAKO DIRECT HDL-C
Chemistry
90d
Cleared
Jun 14, 1996
COMPLEMENT CONTROL
Immunology
102d
Cleared
Feb 16, 1996
WAKO AUTOKIT CRP NEW
Immunology
95d
Cleared
Dec 20, 1995
WAKO AUTOKIT APO B
Immunology
71d
Cleared
Dec 18, 1995
WAKO AUTOKIT CH50
Immunology
104d
Cleared
Oct 05, 1995
WAKO AUTOKIT GLUCOSE
Chemistry
261d
Cleared
Sep 08, 1995
WAKO AUTOKIT APO A1
Immunology
94d
Cleared
Feb 07, 1995
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
Chemistry
138d
Cleared
Aug 20, 1992
WAKO IGG-HA
Immunology
56d
Cleared
Jul 28, 1992
WAKO AUTOKIT RF
Immunology
82d
Cleared
Jul 21, 1992
WAKO AUTOKIT LIPASE-COLOR
Chemistry
127d
Cleared
Jul 14, 1992
WAKO AUTOKIT MICRO TP
Chemistry
160d
Cleared
Jul 19, 1991
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
Chemistry
77d
Cleared
Jun 18, 1990
WAKO(TM) MICRO-ALBUMIN
Chemistry
33d
Cleared
May 14, 1990
WAKO(TM) AUTOKIT URIC ACID
Chemistry
41d
Cleared
Nov 08, 1989
WAKO(TM) AUTOKIT GAMMA-GT
Chemistry
26d
Cleared
Sep 27, 1989
WAKO(TM) AUTOKIT CRP
Chemistry
9d
Cleared
Aug 30, 1988
WAKO(TM) AUTOKIT AMYLASE
Chemistry
42d
Cleared
Jul 08, 1988
WAKO(TM) CRP
Immunology
29d
Cleared
Jun 06, 1988
WAKO(TM) IGG-HA DIRECT
Immunology
101d
Cleared
Mar 29, 1988
WAKO(TM) IGA-HA DIRECT
Immunology
29d
Cleared
Mar 25, 1988
WAKO(TM) IGM-HA DIRECT
Immunology
24d
Cleared
Mar 24, 1988
WAKO(TM) AUTOKIT TOTAL PROTEIN
Chemistry
59d
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