Wako Chemicals USA, Inc. - FDA 510(k) Cleared Devices
124
Total
123
Cleared
1
Denied
89 devices
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
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
Cleared
May 26, 1987
PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR
Chemistry
21d
Cleared
May 26, 1987
TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR
Chemistry
21d
Cleared
May 26, 1987
UREA N STANDARD SOLUTION CALIBRATOR
Chemistry
21d
Cleared
May 26, 1987
URIC ACID STANDARD SOLUTION CALIBRATOR
Chemistry
21d
Cleared
Mar 06, 1987
WAKO(TM) AUTOKIT LDH
Chemistry
32d
Cleared
Feb 13, 1987
WAKO (TM) AUTOKIT GOT TEST
Chemistry
66d
Cleared
Jan 09, 1987
WAKO(TM) AUTOKIT GPT
Chemistry
30d
Cleared
Dec 31, 1986
QKO (TM) AMYLASE B-HA
Chemistry
61d
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