Bill Hyatt

FDA Filings

This page includes the latest FDA filings for Bill Hyatt. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003419906
FEI Number3003419906
NameBill Hyatt
Owner & OperatorFUJIFILM Wako Pure Chemical Corporation
Contact Address1-2 Doshomachi 3-Chome
Chuo-Ku JP-27 Osaka 540-8605 JP
Official Correspondent
  • Tsuyoshi Okamoto
  • 81-6-62033164-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1025 Terra Bella Ave
Mountain View, CA 94043 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3003522182
FEI Number3003522182
NameBill Hyatt
Owner & OperatorFUJIFILM Wako Pure Chemical Corporation
Contact Address1-2 Doshomachi 3-Chome
Chuo-Ku JP-27 Osaka 540-8605 JP
Official Correspondent
  • Tsuyoshi Okamoto
  • 81-6-62033164-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1025 Terra Bella Ave
Mountain View, CA 94043 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Wako Direct Bilirubin V2013-12-16
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Wako Direct Bilirubin V2013-12-16
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
ADVIA Chemistry Enzymatic Creatinine2013-05-09
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
ADVIA Chemistry Total Bilirubin2013-05-09
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako i30 Immunoanalyzer System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako i30 Immunoanalyzer System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Sample Dilution Buffer2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Sample Dilution Buffer2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako i30 Immunoanalyzer System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako i30 Immunoanalyzer System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Sample Dilution Buffer2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Sample Dilution Buffer2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako i30 Immunoanalyzer System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako i30 Immunoanalyzer System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Sample Dilution Buffer2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Sample Dilution Buffer2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako i30 Immunoanalyzer System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako i30 Immunoanalyzer System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Sample Dilution Buffer2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Sample Dilution Buffer2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako i30 Immunoanalyzer System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako i30 Immunoanalyzer System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako DCP Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Sample Dilution Buffer2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Sample Dilution Buffer2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Immunological Test System2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Control L and H2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
uTASWako AFP-L3 Calibrator Set2011-02-28
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Wako HDL-C/LDL-C Calibrator2010-11-05
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Wako HDL-C/LDL-C Calibrator2010-11-05
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Wako Total Bilirubin V2009-07-24
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Wako Total Bilirubin V2009-07-24
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
L-Type Creatinine M2009-03-17
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
L-Type Creatinine M2009-03-17
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
L-Type Creatinine M2009-03-17
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
L-Type Creatinine M2009-03-17
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
NEFA Standard Solution2009-02-09
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
NEFA Standard Solution2009-02-09
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
NEFA Linearity Set2009-02-09
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
NEFA Linearity Set2009-02-09
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
NEFA Linearity Material2009-02-09
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
NEFA Linearity Material2009-02-09
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
L-Type LDL-C2007-12-18
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
L-Type LDL-C2007-12-18
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Complement Control2007-12-18
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Complement Control2007-12-18
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
L-Type HDL-C2007-02-23
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
L-Type HDL-C2007-02-23
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
L-Type HDL-C2007-02-23
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
L-Type HDL-C2007-02-23
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
CH50 Calibrator2007-01-18
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
CH50 Calibrator2007-01-18
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
AUTOKIT CH502007-01-18
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
AUTOKIT CH502007-01-18
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
NEFA-HR 22007-01-18
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
NEFA-HR 22007-01-18
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
MULTIGENT Microalbumin, MULTIGENT Microalbumin Calibrators, MULTIGENT Microalbumin Controls2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
MULTIGENT Microalbumin, MULTIGENT Microalbumin Calibrators, MULTIGENT Microalbumin Controls2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin Control Set2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin Control Set2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin Calibrator Set2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin Calibrator Set2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Reagent Kit2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Reagent Kit2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Controls2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Controls2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Calibrators2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Calibrators2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
MULTIGENT Microalbumin, MULTIGENT Microalbumin Calibrators, MULTIGENT Microalbumin Controls2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
MULTIGENT Microalbumin, MULTIGENT Microalbumin Calibrators, MULTIGENT Microalbumin Controls2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin Control Set2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin Control Set2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin Calibrator Set2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin Calibrator Set2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Reagent Kit2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Reagent Kit2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Controls2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Controls2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Calibrators2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Calibrators2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
MULTIGENT Microalbumin, MULTIGENT Microalbumin Calibrators, MULTIGENT Microalbumin Controls2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
MULTIGENT Microalbumin, MULTIGENT Microalbumin Calibrators, MULTIGENT Microalbumin Controls2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin Control Set2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin Control Set2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin Calibrator Set2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Autokit Micro Albumin Calibrator Set2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Reagent Kit2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Reagent Kit2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Controls2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Controls2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Calibrators2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Alinity c Microalbumin Calibrators2006-03-01
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Multi-Calibrator Lipids2006-01-25
Bill Hyatt [FUJIFILM Wako Pure Chemical Corporation]
Multi-Calibrator Lipids2006-01-25

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