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Wako Chemicals USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
124
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K100464UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DFebruary 23, 2011
K080125APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201July 18, 2008
K080123APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201July 17, 2008
K061775WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATORFebruary 23, 2007
K062368WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBAJanuary 31, 2007
K053132WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791December 30, 2005
K053131WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191December 30, 2005
DEN050002LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYSMay 19, 2005
K042551MULTI-CHEM CALIBRATOR ANovember 16, 2004
K042550MULTI-LIPID CALIBRATORNovember 8, 2004
K042549MULTI CHEM CAL BNovember 8, 2004
K040918WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2May 17, 2004
K033860AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATORApril 23, 2004
K040226WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SETMarch 25, 2004
K024280WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SETJune 6, 2003
K030320WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SETApril 11, 2003
K024281WAKO L-TYPE GLUCOSE 2February 24, 2003
K030065WAKO NEFA LINEARITY SETFebruary 11, 2003
K020972WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SETSeptember 9, 2002
K010332WAKO IMMUNOASSAY CALIBRATOR SETAugust 1, 2001