Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031570369

FEI Number

3031570369

Entity Name

HITACHI HIGH-TECH CORP., Musashimurayama Center

City/State/Country

Musashimurayama Tokyo, JP

Establishment Address

1-26-37 Inadaira, Musashimurayama Tokyo 208-0023, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HITACHI HIGH-TECH CORP. (Owner Number: 9049564)

Owner / Operator Contact Address

1-17-1 Toranomon,, --, Minato-ku, JP-13 105-6409, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Phadia 5000 Phadia 250 Phadia 1000 Phadia 2500

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2024-06-17

Official Correspondent

No official correspondent registered.

US Agent Details

Naomichi Kawasaki Email: naomichi.kawasaki.wv@hitachi-hightech.com Phone: (925) 5586331

Related Public Records

Same Entity

HITACHI HIGH-TECH CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014840402	Hitachi High-Tech Corp., Omuta Center	Omuta-shi Fukuoka, JP
9610865	HITACHI HIGH-TECH CORP., Ome Works	Ome-Shi Tokyo, JP
1000162206	HITACHI HIGH-TECH CORP., KASHIWANOHA	KASHIWA-SHI Chiba, JP
9614673	HITACHI HIGH-TECH CORP., NAKA DIVISION	Hitachinaka-shi Ibaraki, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K874883	Incstar Corp.	WALNUT ALLERGEN DISC	1988-05-11
K935876	Bio-Rad Laboratories, Inc.	ACCESS SPECIFIC IGE ASSAY	1994-03-11
K093987	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6	2011-03-28
K132801	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY	2014-05-28

Similar Registrations

Registration Number	Establishment Name	Location
3039353646	PHADIA AB	Uppsala, SE
3002806944	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED	LLANBERIS Wales, GB
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
9610566	PHADIA AB	UPPSALA, SE
3004973408	PHADIA US INC.	Portage, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031570369. Last updated year: 2026. Please use registration number 3031570369 when referencing this establishment in official correspondence.