Wako Chemicals USA, Inc. - FDA 510(k) Cleared Devices
124
Total
123
Cleared
1
Denied
124 devices
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
Cleared
Nov 23, 1987
PROTEIN STANDARD CALIBRATOR
Chemistry
202d
Cleared
Nov 23, 1987
WAKO(TM) FE C
Chemistry
34d
Cleared
Nov 05, 1987
WAKO(TM) AUTOKIT CK-NAC
Chemistry
84d
Cleared
Oct 02, 1987
WAKO(TM) AUTOKIT ALP
Chemistry
44d
Cleared
Oct 02, 1987
WAKO(TM) AUTOKIT CALCIUM
Chemistry
44d
Cleared
Oct 02, 1987
WAKO(TM) AUTOKIT UREA N
Chemistry
44d
Cleared
Sep 29, 1987
G-GT STANDARD CALIBRATOR
Chemistry
147d
Cleared
Sep 22, 1987
WAKO(TM) PRETEST 8A
Chemistry
25d
Cleared
Sep 18, 1987
CALCIUM CALIBRATOR
Chemistry
113d
Cleared
Sep 16, 1987
WAKO(TM) ZN TEST
Chemistry
343d
Cleared
Aug 11, 1987
GIT SERUM-FREE MEDIUM FOR CELL CULTURE
Pathology
15d
Cleared
Jul 22, 1987
TOTAL BILIRUBIN STANDARD CALIBRATOR
Chemistry
40d
Cleared
Jun 03, 1987
BILIRUBIN TESTER
Chemistry
145d
Cleared
May 27, 1987
CREATININE STANDARD SOLUTION CALIBRATOR
Chemistry
22d
Cleared
May 26, 1987
GLUCOSE STANDARD SOLUTION CALIBRATOR
Chemistry
21d
Cleared
May 26, 1987
MAGNESIUM STANDARD SOLUTION CALIBRATOR
Chemistry
21d
Cleared
May 26, 1987
NEFA STANDARD SOLUTION CALIBRATOR
Chemistry
21d
Cleared
May 26, 1987
INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR
Chemistry
21d
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