Wako Chemicals Usa Inc

FDA Filings

This page includes the latest FDA filings for Wako Chemicals Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
WAKO CHEMICALS USA, INC.
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION2011-02-23
WAKO CHEMICALS USA, INC.
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-252012008-07-18
WAKO CHEMICALS USA, INC.
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-252012008-07-17
WAKO CHEMICALS, USA, INC.
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR2007-02-23
WAKO CHEMICALS, USA, INC.
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-054012007-01-31
WAKO CHEMICALS, USA, INC.
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-237912005-12-30
WAKO CHEMICALS, USA, INC.
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-231912005-12-30
WAKO CHEMICALS, USA, INC.
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS2005-05-19
WAKO CHEMICALS, USA, INC.
MULTI-CHEM CALIBRATOR A2004-11-16
WAKO CHEMICALS, USA, INC.
MULTI-LIPID CALIBRATOR2004-11-08
WAKO CHEMICALS, USA, INC.
MULTI CHEM CAL B2004-11-08
WAKO CHEMICALS, USA, INC.
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR2004-04-23
WAKO CHEMICALS, USA, INC.
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET2003-06-06
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET2003-04-11
WAKO CHEMICALS, USA, INC.
WAKO L-TYPE GLUCOSE 22003-02-24
WAKO CHEMICALS, USA, INC.
WAKO NEFA LINEARITY SET2003-02-11
WAKO CHEMICALS, USA, INC.
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET2002-09-09
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT C32001-06-25
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT C42001-06-25
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX2000-07-24
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO2000-07-24
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET2000-07-24
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA2000-07-24
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT LP(A)/EXPRESS 5502000-07-23
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT LP(A)/ RA,500/1000,2000-07-23
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT LP(A)/DADE DEMENSION2000-07-23
WAKO CHEMICALS, USA, INC.
WAKO HDL-C/LDL-C CALIBRATOR2000-06-01
WAKO CHEMICALS, USA, INC.
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR2000-06-01
WAKO CHEMICALS, USA, INC.
WAKO LIPASE CALIBRATOR2000-05-24
WAKO CHEMICALS, USA, INC.
WAKO L-TYPE UN TEST2000-04-03
WAKO CHEMICALS, USA, INC.
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD2000-01-18
WAKO CHEMICALS, USA, INC.
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD2000-01-14
WAKO CHEMICALS, USA, INC.
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD2000-01-14
WAKO CHEMICALS, USA, INC.
WAKO L-TYPE GOT TEST1999-12-16
WAKO CHEMICALS, USA, INC.
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR1999-11-12
WAKO CHEMICALS, USA, INC.
WAKO L-TYPE UA F TEST1999-11-09
WAKO CHEMICALS, USA, INC.
WAKO L-TYPE TRIGLYCERIDE TEST1999-11-09
WAKO CHEMICALS, USA, INC.
WAKO BILIRUBIN CALIBRATOR1999-11-09
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT LP(A)1999-03-09
WAKO CHEMICALS, USA, INC.
WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR1999-01-20
WAKO CHEMICALS, USA, INC.
WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR1999-01-15
WAKO CHEMICALS, USA, INC.
WAKO L-TYPE AMYLASE1999-01-13
WAKO CHEMICALS, USA, INC.
WAKO DIRECT LDL-C1998-09-22
WAKO CHEMICALS, USA, INC.
WAKO CH50 LINEARITY SET1997-09-25
WAKO CHEMICALS, USA, INC.
WAKO NEFA LINEARITY SET1997-09-12
WAKO CHEMICALS, USA, INC.
WAKO DIRECT BILIRUBIN V1997-05-07
WAKO CHEMICALS, USA, INC.
WAKO TOTAL BILIRUBIN V1997-04-21
WAKO CHEMICALS, USA, INC.
WAKO DIRECT HDL-C1996-12-24
WAKO CHEMICALS, USA, INC.
COMPLEMENT CONTROL1996-06-14
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT CRP NEW1996-02-16
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT APO B1995-12-20
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT CH501995-12-18
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT GLUCOSE1995-10-05
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT APO A11995-09-08
WAKO CHEMICALS, USA, INC.
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR1995-02-07
WAKO CHEMICALS, USA, INC.
WAKO IGG-HA1992-08-20
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT RF1992-07-28
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT LIPASE-COLOR1992-07-21
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT MICRO TP1992-07-14
WAKO CHEMICALS, USA, INC.
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)1991-07-19
WAKO CHEMICALS, USA, INC.
WAKO(TM) MICRO-ALBUMIN1990-06-18
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT URIC ACID1990-05-14
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT GAMMA-GT1989-11-08
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT GAMMA-GT1989-11-08
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT CRP1989-09-27
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT AMYLASE1988-08-30
WAKO CHEMICALS, USA, INC.
WAKO(TM) CRP1988-07-08
WAKO CHEMICALS, USA, INC.
WAKO(TM) IGG-HA DIRECT1988-06-06
WAKO CHEMICALS, USA, INC.
WAKO(TM) IGA-HA DIRECT1988-03-29
WAKO CHEMICALS, USA, INC.
WAKO(TM) IGM-HA DIRECT1988-03-25
WAKO CHEMICALS, USA, INC.
WAKO AUTOKIT URIC ACID1988-03-24
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT ALBUMIN1988-03-24
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT TOTAL PROTEIN1988-03-24
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT CHOLESTEROL1988-03-01
WAKO CHEMICALS, USA, INC.
WAKO(TM) PRETEST 6A1988-02-11
WAKO CHEMICALS, USA, INC.
WAKO(TM) UIBC1988-02-02
WAKO CHEMICALS, USA, INC.
WAKO(TM) PRETEST 5A1988-01-21
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT LIPASE1987-12-22
WAKO CHEMICALS, USA, INC.
WAKO(TM) FE C1987-11-23
WAKO CHEMICALS, USA, INC.
PROTEIN STANDARD CALIBRATOR1987-11-23
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT CK-NAC1987-11-05
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT UREA N1987-10-02
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT CALCIUM1987-10-02
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT ALP1987-10-02
WAKO CHEMICALS, USA, INC.
G-GT STANDARD CALIBRATOR1987-09-29
WAKO CHEMICALS, USA, INC.
WAKO(TM) PRETEST 8A1987-09-22
WAKO CHEMICALS, USA, INC.
CALCIUM CALIBRATOR1987-09-18
WAKO CHEMICALS, USA, INC.
WAKO(TM) ZN TEST1987-09-16
WAKO CHEMICALS, USA, INC.
GIT SERUM-FREE MEDIUM FOR CELL CULTURE1987-08-11
WAKO CHEMICALS, USA, INC.
TOTAL BILIRUBIN STANDARD CALIBRATOR1987-07-22
WAKO CHEMICALS, USA, INC.
BILIRUBIN TESTER1987-06-03
WAKO CHEMICALS, USA, INC.
CREATININE STANDARD SOLUTION CALIBRATOR1987-05-27
WAKO CHEMICALS, USA, INC.
URIC ACID STANDARD SOLUTION CALIBRATOR1987-05-26
WAKO CHEMICALS, USA, INC.
UREA N STANDARD SOLUTION CALIBRATOR1987-05-26
WAKO CHEMICALS, USA, INC.
TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR1987-05-26
WAKO CHEMICALS, USA, INC.
PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR1987-05-26
WAKO CHEMICALS, USA, INC.
INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR1987-05-26
WAKO CHEMICALS, USA, INC.
NEFA STANDARD SOLUTION CALIBRATOR1987-05-26
WAKO CHEMICALS, USA, INC.
MAGNESIUM STANDARD SOLUTION CALIBRATOR1987-05-26
WAKO CHEMICALS, USA, INC.
GLUCOSE STANDARD SOLUTION CALIBRATOR1987-05-26
WAKO CHEMICALS, USA, INC.
WAKO(TM) AUTOKIT LDH1987-03-06

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2018072045037Kobe,Japan -> Los Angeles, CaliforniaMACHINES & MECHANICAL APPLIANCES WITH INDIVID UAL FUNCTION NEW1 CAS
201805149099Pusan,South Korea -> New York/Newark Area, Newark, New JerseyGLASS VIALS2 CRT
201805084512Kobe,Japan -> Norfolk, VirginiaSODIUM CARBONATE HS CODE : 2836.2020 CRT
20180505830Pusan,South Korea -> Norfolk, Virginia2,2' - AZODI ISOBUTYRO NITRILE (ABN-R) H.S. C .800 CTN
20180505830Pusan,South Korea -> Norfolk, Virginia2,2' - AZODI ISOBUTYRO NITRILE (ABN-R) H.S. C .800 CTN
201804241029Hong Kong,Hong Kong -> Norfolk, VirginiaN H CHEMICAL CHELEST 2K ETHYLENE GLYCOL POTASSIUM HYDROGEN PHTHALATE294 PCS
2018042018164Kaohsiung,China (Taiwan) -> Seattle, Washington730-18906 CLEAN-3141(EX) HS CODE 9025.19,3402.90 (18 DRM, 1 PCS)19 PKG
2018042015972Tokyo ,Japan -> Charleston, South Carolina10 PKG (15 FIBERBOARD BOX (INNER PLASTIC BAG) + 246 FIBER DRUM) __AMORRIS@SEAMODAL.COM EXPORT CONTACT_MR. LES WILSON EXPORT30@SEAMODAL.COM 51 DRUM261 PCS
2018041611609Kaohsiung,China (Taiwan) -> Seattle, Washington730-18906 CLEAN-3141(EX) HS CODE 3402.90 9205.19 (22 DRM, 1 PCS)23 PKG

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