Hitachi Chemical Diagnostics Systems Co L T D

FDA Filings

This page includes the latest FDA filings for Hitachi Chemical Diagnostics Systems Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3002694097
• FEI Number: 3002694097
• Name: Donald Postel
• Owner & Operator: Hitachi Chemical Diagnostics Systems Co., Ltd.
• Contact Address: 8-10, 1 CHOME HARUMI, CHUO-KU --; TOKYO JP-NOTA 104 JP
• Official Correspondent:
  • Kazuhiko - Tamaki
  • 81-3-62197617-x
• US Agent:
  • Donald Postel
  • Hitachi Chemical Diagnostics, Inc.
  • 650 2102650
  • 650 9692745
  • donp@hcdiagnostics.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 630 Clyde Ct., Mountain View ; Mountain View, CA 94043 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K162538 | JJX Donald Postel [Hitachi Chemical Diagnostics Systems Co., Ltd.]	IRI MCM	2018-07-24
PMN K162538 | JJX Donald Postel [Hitachi Chemical Diagnostics Systems Co., Ltd.]	IRI Calibrator (2-pack)	2018-07-24
PMN K162538 | JIT Donald Postel [Hitachi Chemical Diagnostics Systems Co., Ltd.]	IRI MCM	2018-07-24
PMN K162538 | JIT Donald Postel [Hitachi Chemical Diagnostics Systems Co., Ltd.]	IRI Calibrator (2-pack)	2018-07-24
PMN K021535 | JIT Donald Postel [Hitachi Chemical Diagnostics Systems Co., Ltd.]	IRI Calibrator (2-pack)	2012-12-19
JKD Donald Postel [Hitachi Chemical Diagnostics Systems Co., Ltd.]	CpS Assay Kit (1-pack)	2002-07-11
CFP Donald Postel [Hitachi Chemical Diagnostics Systems Co., Ltd.]	IRI Diluent (2-pack)	2002-07-11
CFP Donald Postel [Hitachi Chemical Diagnostics Systems Co., Ltd.]	IRI Diluent (10 mL)	2002-07-11
CFP Donald Postel [Hitachi Chemical Diagnostics Systems Co., Ltd.]	IRI Assay Kit (1-pack)	2002-07-11