Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610865

FEI Number

3002806350

Entity Name

HITACHI HIGH-TECH CORP., Ome Works

City/State/Country

Ome-Shi Tokyo, JP

Establishment Address

3-7-19, Imai, Ome-Shi Tokyo 198-8577, 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

CCM Vertical Elevator Unit CCM Vertical Overhead Conveyor Unit (1m) Modular Pre-Analytics cobas 8100 automated workflow series CONVEYOR 3 Unit Modular Connection Unit Linear Buffer Unit OUTPUT UNIT Cobas 6000 Connection Unit Add-On Buffer Unit CCM Backend Connection Unit CCM Vertical Turntable Unit Cobas 8000 Connection Unit CCM Vertical Power Box Unit CONVEYOR 1 Unit CCM Address Extension Unit Power Supply Unit CONVEYOR 2 Unit CCM Bidirectional Interface Turn Unit HST Connection Unit CCM cobas c513 Connection Unit CONVEYOR 4 Unit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOX	Automated Occult Blood Analyzer	Hematology	Class 2	864.6550	2026-01-05
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2014-11-24

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
1000162206	HITACHI HIGH-TECH CORP., KASHIWANOHA	KASHIWA-SHI Chiba, JP
3031570369	HITACHI HIGH-TECH CORP., Musashimurayama Center	Musashimurayama Tokyo, JP
9614673	HITACHI HIGH-TECH CORP., NAKA DIVISION	Hitachinaka-shi Ibaraki, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

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2435505	POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.	CORTLANDT MANOR, NY, US
3017923561	SARIS AND THINGS, INC.	Plainfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610865. Last updated year: 2026. Please use registration number 9610865 when referencing this establishment in official correspondence.