Wako Chemicals USA, Inc. - FDA 510(k) Cleared Devices
124
Total
123
Cleared
1
Denied
124 devices
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
Cleared
Dec 16, 1986
WAKO(TM) GOT II - HA
Chemistry
46d
Cleared
Dec 16, 1986
WAKO GPT II - HA
Chemistry
42d
Cleared
Aug 19, 1986
WAKO MICRO TP
Chemistry
118d
Cleared
Dec 11, 1984
WAKO AUTOMATED REAGENTS FOR HITACHI 705
Hematology
144d
Cleared
Aug 15, 1984
WAKO LDH CII TEST
Chemistry
54d
Cleared
Feb 03, 1984
MAGNESIUM B TEST
Chemistry
70d
Cleared
Dec 08, 1983
WAKO GLUCOSE C
Chemistry
79d
Cleared
Aug 11, 1983
WAKO CPK TEST
Chemistry
50d
Cleared
Jul 18, 1983
WAKO R-GTP C-TEST
Chemistry
56d
Cleared
Jul 18, 1983
WAKO CHOLESTEROL CII
Pathology
55d
Cleared
Apr 18, 1983
WAKO FREE CHOLESTEROL C TEST
Chemistry
39d
Cleared
Mar 29, 1983
FEB TEST
Chemistry
34d
Cleared
Jan 28, 1983
WAKO INSULIN TEST
Chemistry
30d
Cleared
Feb 12, 1982
WAKO CALCIUM C TEST
Chemistry
14d
Cleared
Aug 12, 1981
WAKO NEFA C TEST
Chemistry
21d
Cleared
Jun 09, 1981
WAKO URIC ACID B TEST
Chemistry
13d
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