Fujifilm Wako Diagnostics U S A Corp

FDA Filings

This page includes the latest FDA filings for Fujifilm Wako Diagnostics U S A Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Fujifilm Wako Diagnostics U S A Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Bill Hyatt

FDA Registration(s)

• Registration Number: 1627434
• FEI Number: 1627434
• Name: FUJIFILM Wako Diagnostics U.S.A. Corporation
• Owner & Operator: FUJIFILM Wako Pure Chemical Corporation
• Contact Address: 1-2 Doshomachi 3-Chome ; Chuo-Ku JP-27 Osaka 540-8605 JP
• Official Correspondent:
  • Tsuyoshi Okamoto
  • 81-6-62033164-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1600 BELLWOOD ROAD ; N Chesterfld, VA 23237 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3009907123
• FEI Number: 3009907123
• Name: FUJIFILM Wako Diagnostics U.S.A. Corporation
• Owner & Operator: FUJIFILM Wako Pure Chemical Corporation
• Contact Address: 1-2 Doshomachi 3-Chome ; Chuo-Ku JP-27 Osaka 540-8605 JP
• Official Correspondent:
  • Tsuyoshi Okamoto
  • 81-6-62033164-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1025 Terra Bella Ave ; Mountain View, CA 94043 US

FDA Filings

Device Company	Device	Date
PMN K053132 | JFM FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Wako Direct Bilirubin V	2013-12-16
PMN K100464 | OUE FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako i30 Immunoanalyzer System	2011-02-28
PMN K100464 | OUE FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Immunological Test System	2011-02-28
PMN K100464 | OUE FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Control L and H	2011-02-28
PMN K100464 | OUE FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Calibrator Set	2011-02-28
PMN K100464 | OUE FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Sample Dilution Buffer	2011-02-28
PMN K100464 | OUE FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Immunological Test System	2011-02-28
PMN K100464 | OUE FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Control L and H	2011-02-28
PMN K100464 | OUE FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Calibrator Set	2011-02-28
PMN K100464 | OAU FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako i30 Immunoanalyzer System	2011-02-28
PMN K100464 | OAU FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Immunological Test System	2011-02-28
PMN K100464 | OAU FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Control L and H	2011-02-28
PMN K100464 | OAU FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Calibrator Set	2011-02-28
PMN K100464 | OAU FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Sample Dilution Buffer	2011-02-28
PMN K100464 | OAU FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Immunological Test System	2011-02-28
PMN K100464 | OAU FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Control L and H	2011-02-28
PMN K100464 | OAU FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Calibrator Set	2011-02-28
PMN K100464 | NSF FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako i30 Immunoanalyzer System	2011-02-28
PMN K100464 | NSF FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Immunological Test System	2011-02-28
PMN K100464 | NSF FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Control L and H	2011-02-28
PMN K100464 | NSF FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Calibrator Set	2011-02-28
PMN K100464 | NSF FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Sample Dilution Buffer	2011-02-28
PMN K100464 | NSF FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Immunological Test System	2011-02-28
PMN K100464 | NSF FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Control L and H	2011-02-28
PMN K100464 | NSF FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Calibrator Set	2011-02-28
PMN K100464 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako i30 Immunoanalyzer System	2011-02-28
PMN K100464 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Immunological Test System	2011-02-28
PMN K100464 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Control L and H	2011-02-28
PMN K100464 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Calibrator Set	2011-02-28
PMN K100464 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Sample Dilution Buffer	2011-02-28
PMN K100464 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Immunological Test System	2011-02-28
PMN K100464 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Control L and H	2011-02-28
PMN K100464 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Calibrator Set	2011-02-28
PMN K100464 | JIT FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako i30 Immunoanalyzer System	2011-02-28
PMN K100464 | JIT FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Immunological Test System	2011-02-28
PMN K100464 | JIT FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Control L and H	2011-02-28
PMN K100464 | JIT FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako DCP Calibrator Set	2011-02-28
PMN K100464 | JIT FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Sample Dilution Buffer	2011-02-28
PMN K100464 | JIT FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Immunological Test System	2011-02-28
PMN K100464 | JIT FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Control L and H	2011-02-28
PMN K100464 | JIT FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	uTASWako AFP-L3 Calibrator Set	2011-02-28
PMN K001005 | JIS FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Wako HDL-C/LDL-C Calibrator	2010-11-05
PMN K053131 | JFM FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Wako Total Bilirubin V	2009-07-24
PMN K871763 | JIT FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	NEFA Standard Solution	2009-02-09
PMN K030065 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	NEFA Linearity Set	2009-02-09
PMN K030065 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	NEFA Linearity Material	2009-02-09
PMN K982271 | MRR FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	L-Type LDL-C	2007-12-18
PMN K960874 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Complement Control	2007-12-18
PMN K963847 | LBR FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	L-Type HDL-C	2007-02-23
PMN K963847 | JIS FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	L-Type HDL-C	2007-02-23
PMN K954145 | DAE FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	CH50 Calibrator	2007-01-18
PMN K954145 | DAE FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	AUTOKIT CH50	2007-01-18
JLH FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	NEFA-HR 2	2007-01-18
PMN K030320 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	MULTIGENT Microalbumin, MULTIGENT Microalbumin Calibrators, MULTIGENT Microalbumin Controls	2006-03-01
PMN K030320 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Autokit Micro Albumin	2006-03-01
PMN K030320 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Autokit Micro Albumin Control Set	2006-03-01
PMN K030320 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Autokit Micro Albumin Calibrator Set	2006-03-01
PMN K030320 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Alinity c Microalbumin Reagent Kit	2006-03-01
PMN K030320 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Alinity c Microalbumin Controls	2006-03-01
PMN K030320 | JJX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Alinity c Microalbumin Calibrators	2006-03-01
PMN K030320 | JIS FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	MULTIGENT Microalbumin, MULTIGENT Microalbumin Calibrators, MULTIGENT Microalbumin Controls	2006-03-01
PMN K030320 | JIS FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Autokit Micro Albumin	2006-03-01
PMN K030320 | JIS FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Autokit Micro Albumin Control Set	2006-03-01
PMN K030320 | JIS FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Autokit Micro Albumin Calibrator Set	2006-03-01
PMN K030320 | JIS FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Alinity c Microalbumin Reagent Kit	2006-03-01
PMN K030320 | JIS FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Alinity c Microalbumin Controls	2006-03-01
PMN K030320 | JIS FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Alinity c Microalbumin Calibrators	2006-03-01
PMN K030320 | JIQ FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	MULTIGENT Microalbumin, MULTIGENT Microalbumin Calibrators, MULTIGENT Microalbumin Controls	2006-03-01
PMN K030320 | JIQ FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Autokit Micro Albumin	2006-03-01
PMN K030320 | JIQ FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Autokit Micro Albumin Control Set	2006-03-01
PMN K030320 | JIQ FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Autokit Micro Albumin Calibrator Set	2006-03-01
PMN K030320 | JIQ FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Alinity c Microalbumin Reagent Kit	2006-03-01
PMN K030320 | JIQ FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Alinity c Microalbumin Controls	2006-03-01
PMN K030320 | JIQ FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Alinity c Microalbumin Calibrators	2006-03-01
PMN K042550 | JIX FUJIFILM Wako Diagnostics U.S.A. Corporation [FUJIFILM Wako Pure Chemical Corporation]	Multi-Calibrator Lipids	2006-01-25

Related Finance Registrations

NCAGE Code	6UKZ8	FUJIFILM WAKO DIAGNOSTICS U.S.A.!CORPORATION!DBA WAKO
CAGE Code	6UKZ8	FUJIFILM WAKO DIAGNOSTICS U.S.A. CORPORATION WAKO
S.A.M. Registration	6UKZ8 [78629716]	FUJIFILM WAKO DIAGNOSTICS U.S.A. CORPORATION WAKO