Wako Chemicals USA, Inc. - FDA 510(k) Cleared Devices
124
Total
123
Cleared
1
Denied
89 devices
Cleared
Jan 20, 1999
WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR
Chemistry
63d
Cleared
Jan 15, 1999
WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR
Chemistry
58d
Cleared
Jan 13, 1999
WAKO L-TYPE AMYLASE
Chemistry
51d
Cleared
Sep 22, 1998
WAKO DIRECT LDL-C
Chemistry
85d
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
Oct 05, 1995
WAKO AUTOKIT GLUCOSE
Chemistry
261d
Cleared
Feb 07, 1995
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
Chemistry
138d
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
Mar 24, 1988
WAKO(TM) AUTOKIT TOTAL PROTEIN
Chemistry
59d
Cleared
Mar 24, 1988
WAKO(TM) AUTOKIT ALBUMIN
Chemistry
59d
Cleared
Mar 24, 1988
WAKO AUTOKIT URIC ACID
Chemistry
29d
Cleared
Mar 01, 1988
WAKO(TM) AUTOKIT CHOLESTEROL
Chemistry
36d
Cleared
Feb 11, 1988
WAKO(TM) PRETEST 6A
Chemistry
170d
Cleared
Feb 02, 1988
WAKO(TM) UIBC
Chemistry
47d
Cleared
Jan 21, 1988
WAKO(TM) PRETEST 5A
Chemistry
153d
Cleared
Dec 22, 1987
WAKO(TM) AUTOKIT LIPASE
Chemistry
40d
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