Hitachi High Tech Corp

FDA Filings

This page includes the latest FDA filings for Hitachi High Tech Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

JAPAN

TOKYO STOCK EXCHANGE

8036

DUNS 690539606

FDA Registration(s)

• Registration Number: 9614673
• FEI Number: 3003559576
• Name: Tomoyuki Koshikawa
• Owner & Operator: HITACHI HIGH-TECH CORP.
• Contact Address: 1-17-1 Toranomon, --; Minato-ku JP-13 Tokyo 105-6409 JP
• US Agent:
  • Tomoyuki Koshikawa
  • 408 2065299
  • tomoyuki.koshikawa@hitachi-hta.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5201 Great America Parkway Suite 236; Santa Clara, CA 95054 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3014840402
• FEI Number: 3014840402
• Name: Hitachi High-Technologies Corp., Omuta Center
• Owner & Operator: HITACHI HIGH-TECH CORP.
• Contact Address: 1-17-1 Toranomon, --; Minato-ku JP-13 Tokyo 105-6409 JP
• US Agent:
  • Tomoyuki Koshikawa
  • 408 2065299
  • tomoyuki.koshikawa@hitachi-hta.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1892-1 Tegama ; Omuta-shi, Fukuoka, 836-0004 JP
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K191899 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas pro integrated solutions	2019-08-19
PMN K191899 | JGS Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas pro integrated solutions	2019-08-19
PMN K162606 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas e 801 Immunoassay Analyzer	2017-06-02
PMN K160571 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas c 513 Analyzer	2017-01-16
LXG Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Clinical Laboratory Automation System (CLAS)	2014-11-27
LXG Hitachi High-Technologies Corp., Omuta Center [HITACHI HIGH-TECH CORP.]	Clinical Laboratory Automation System (CLAS)	2014-11-27
JQP Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas 8100 automated workflow series	2014-11-24
JQP Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Modular Pre-Analytics	2014-11-24
JQP Hitachi High-Technologies Corp., Omuta Center [HITACHI HIGH-TECH CORP.]	cobas 8100 automated workflow series	2014-11-24
JQP Hitachi High-Technologies Corp., Omuta Center [HITACHI HIGH-TECH CORP.]	Modular Pre-Analytics	2014-11-24
PMN K961481 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	e411	2014-11-04
PMN K961481 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	MODULAR E	2014-11-04
PMN K961481 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	ELECSYS 2010 ANALYZER	2014-11-04
PMN K961481 | JJE Hitachi High-Technologies Corp., Omuta Center [HITACHI HIGH-TECH CORP.]	e411	2014-11-04
PMN K961481 | JJE Hitachi High-Technologies Corp., Omuta Center [HITACHI HIGH-TECH CORP.]	MODULAR E	2014-11-04
PMN K961481 | JJE Hitachi High-Technologies Corp., Omuta Center [HITACHI HIGH-TECH CORP.]	ELECSYS 2010 ANALYZER	2014-11-04
PMN K942364 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Hitachi 914	2013-06-05
PMN K060373 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas 6000 Series System (c501 and e601 Module)	2013-03-11
PMN K060373 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	c311	2013-03-11
PMN K060373 | JGS Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas 6000 Series System (c501 and e601 Module)	2013-03-11
PMN K060373 | JGS Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	c311	2013-03-11
PMN K060373 | CGZ Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas 6000 Series System (c501 and e601 Module)	2013-03-11
PMN K060373 | CGZ Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	c311	2013-03-11
PMN K060373 | CEM Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas 6000 Series System (c501 and e601 Module)	2013-03-11
PMN K060373 | CEM Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	c311	2013-03-11
PMN K100853 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas 8000 Modular Analyzer Series (c502, c701, c702, e602 and ISE Module)	2013-03-06
PMN K100853 | JGS Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas 8000 Modular Analyzer Series (c502, c701, c702, e602 and ISE Module)	2013-03-06
PMN K100853 | CGZ Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas 8000 Modular Analyzer Series (c502, c701, c702, e602 and ISE Module)	2013-03-06
PMN K100853 | CEM Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	cobas 8000 Modular Analyzer Series (c502, c701, c702, e602 and ISE Module)	2013-03-06
PMN K953239 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	MODULAR P	2013-03-05
PMN K953239 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	ISE MODULAR	2013-03-05
PMN K953239 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Hitachi 917 with ISE	2013-03-05
PMN K953239 | JGS Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	MODULAR P	2013-03-05
PMN K953239 | JGS Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	ISE MODULAR	2013-03-05
PMN K953239 | JGS Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Hitachi 917 with ISE	2013-03-05
PMN K953239 | CGZ Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	MODULAR P	2013-03-05
PMN K953239 | CGZ Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	ISE MODULAR	2013-03-05
PMN K953239 | CGZ Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Hitachi 917 with ISE	2013-03-05
PMN K953239 | CEM Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	MODULAR P	2013-03-05
PMN K953239 | CEM Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	ISE MODULAR	2013-03-05
PMN K953239 | CEM Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Hitachi 917 with ISE	2013-03-05
PMN K921661 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Hitachi 912	2013-03-05
PMN K921661 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Hitachi 911	2013-03-05
PMN K921661 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Hitachi 902	2013-03-05
PMN K872494 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Hitachi 717	2013-03-05
PMN K860748 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Hitachi 736	2013-03-05
PMN K811194 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	HITACHI 705 AUTOMATIC BLOOD CHEMISTRY	2013-03-05
PMN K854025 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Hitachi 704	2013-02-14
PMN K843283 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	Hitachi 737	2013-02-14
PMN K901003 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	MODULAR D	2013-01-31
PMN K901003 | JJE Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	HITACHI 747	2013-01-31
KQO Tomoyuki Koshikawa [HITACHI HIGH-TECH CORP.]	HITACHI CHEMISTRIP SUPPER UA	1998-01-08

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092651293	Tokyo ,Japan -> Los Angeles, California	PISTON FOR AUTOMOTIVE	1604 CTN
2020092651293	Tokyo ,Japan -> Los Angeles, California	PISTON FOR AUTOMOTIVE	1604 CTN
2020092651293	Tokyo ,Japan -> Los Angeles, California	PISTON FOR AUTOMOTIVE	1604 CTN
2020092651293	Tokyo ,Japan -> Los Angeles, California	PISTON FOR AUTOMOTIVE	1604 CTN
2020092554806	Tokyo ,Japan -> Los Angeles, California	PISTON FOR AUTOMOTIVE	1075 PKG
2020092554806	Tokyo ,Japan -> Los Angeles, California	PISTON FOR AUTOMOTIVE	1075 PKG
2020092554806	Tokyo ,Japan -> Los Angeles, California	PISTON FOR AUTOMOTIVE	1075 PKG
2020092554806	Tokyo ,Japan -> Los Angeles, California	PISTON FOR AUTOMOTIVE	1075 PKG
2020092547193	Nagoya Ko ,Japan -> Tacoma, Washington	MACHINES FOR MANUFACTURE OF SEMICONDUCTOR DE	14 CAS
2020092547193	Nagoya Ko ,Japan -> Tacoma, Washington	MACHINES FOR MANUFACTURE OF SEMICONDUCTOR DE	14 CAS
2020092547193	Nagoya Ko ,Japan -> Tacoma, Washington	MACHINES FOR MANUFACTURE OF SEMICONDUCTOR DE	14 CAS
2020092547193	Nagoya Ko ,Japan -> Tacoma, Washington	MACHINES FOR MANUFACTURE OF SEMICONDUCTOR DE	14 CAS
2020092547194	Nagoya Ko ,Japan -> Tacoma, Washington	MACHINES FOR MANUFACTURE OF SEMICONDUCTOR DE	14 CAS
2020092547194	Nagoya Ko ,Japan -> Tacoma, Washington	MACHINES FOR MANUFACTURE OF SEMICONDUCTOR DE	14 CAS
2020092547194	Nagoya Ko ,Japan -> Tacoma, Washington	MACHINES FOR MANUFACTURE OF SEMICONDUCTOR DE	14 CAS
2020092547322	Tokyo ,Japan -> Tacoma, Washington	TU & DCR UPGRADE FOR SEMICONDUCTOR ETCHING SYSTEM MODEL M-9010XT(PEC938) HS CODE:8486.40 . . .	4 CAS
2020092430013	Tokyo ,Japan -> Los Angeles, California	PISTON FOR AUTOMOTIVE	1448 CTN
2020092430013	Tokyo ,Japan -> Los Angeles, California	PISTON FOR AUTOMOTIVE	1448 CTN
2020092430013	Tokyo ,Japan -> Los Angeles, California	PISTON FOR AUTOMOTIVE	1448 CTN
2020092430013	Tokyo ,Japan -> Los Angeles, California	PISTON FOR AUTOMOTIVE	1448 CTN
2020092449877	Nagoya Ko ,Japan -> Tacoma, Washington	MACHINES FOR MANUFACTURE OF SEMICONDUCTOR DE	14 CAS
2020092449877	Nagoya Ko ,Japan -> Tacoma, Washington	MACHINES FOR MANUFACTURE OF SEMICONDUCTOR DE	14 CAS
2020092449877	Nagoya Ko ,Japan -> Tacoma, Washington	MACHINES FOR MANUFACTURE OF SEMICONDUCTOR DE	14 CAS
2020092449877	Nagoya Ko ,Japan -> Tacoma, Washington	MACHINES FOR MANUFACTURE OF SEMICONDUCTOR DE	14 CAS
2020092436958	Kobe,Japan -> Los Angeles, California	PARTS FOR TAPS FOR PIPE VAT INCLUDING PRESSU	11 CAS