Wako Chemicals USA, Inc. - FDA 510(k) Cleared Devices
124
Total
123
Cleared
1
Denied
30 devices
Cleared
Feb 23, 2011
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL...
Immunology
370d
Cleared
Jan 31, 2007
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301
Immunology
170d
Not Cleared
May 19, 2005
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
Immunology
42d
Cleared
Sep 09, 2002
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
Immunology
167d
Cleared
Aug 01, 2001
WAKO IMMUNOASSAY CALIBRATOR SET
Immunology
180d
Cleared
Jun 25, 2001
WAKO AUTOKIT C4
Immunology
143d
Cleared
Jun 25, 2001
WAKO AUTOKIT C3
Immunology
143d
Cleared
Jun 25, 2001
WAKO LIPID CALIBRATOR
Immunology
143d
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