Wako Chemicals USA, Inc. - FDA 510(k) Cleared Devices
124
Total
123
Cleared
1
Denied
124 devices
Cleared
Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
Immunology
28d
Cleared
Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
Immunology
28d
Cleared
Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
Immunology
28d
Cleared
Jul 23, 2000
WAKO AUTOKIT LP(A)/DADE DEMENSION
Immunology
30d
Cleared
Jul 23, 2000
WAKO AUTOKIT LP(A)/ RA,500/1000,
Immunology
30d
Cleared
Jul 23, 2000
WAKO AUTOKIT LP(A)/EXPRESS 550
Immunology
30d
Cleared
Jun 01, 2000
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
Chemistry
64d
Cleared
Jun 01, 2000
WAKO HDL-C/LDL-C CALIBRATOR
Chemistry
64d
Cleared
May 24, 2000
WAKO LIPASE CALIBRATOR
Chemistry
56d
Cleared
Apr 03, 2000
WAKO L-TYPE UN TEST
Chemistry
137d
Cleared
Jan 18, 2000
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
Immunology
61d
Cleared
Jan 14, 2000
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
Immunology
57d
Cleared
Jan 14, 2000
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
Immunology
57d
Cleared
Dec 16, 1999
WAKO L-TYPE GOT TEST
Chemistry
64d
Cleared
Nov 12, 1999
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
Immunology
51d
Cleared
Nov 09, 1999
WAKO BILIRUBIN CALIBRATOR
Chemistry
43d
Cleared
Nov 09, 1999
WAKO L-TYPE TRIGLYCERIDE TEST
Chemistry
27d
Cleared
Nov 09, 1999
WAKO L-TYPE UA F TEST
Chemistry
27d
Cleared
Mar 09, 1999
WAKO AUTOKIT LP(A)
Chemistry
321d
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
Sep 25, 1997
WAKO CH50 LINEARITY SET
Immunology
41d
Cleared
Sep 12, 1997
WAKO NEFA LINEARITY SET
Toxicology
25d
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