Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014840402

FEI Number

3014840402

Entity Name

Hitachi High-Tech Corp., Omuta Center

City/State/Country

Omuta-shi Fukuoka, JP

Establishment Address

1892-1 Tegama, Omuta-shi Fukuoka 836-0004, 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 Clinical Laboratory Automation System (CLAS) Dummy HPLC Cartridge Dummy Rapid Cartridge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2014-11-24
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2014-11-27

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
9610865	HITACHI HIGH-TECH CORP., Ome Works	Ome-Shi Tokyo, 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
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3013922172	INDIGO BIOAUTOMATION, INC.	Carmel, IN, US
3012436569	NATIONAL TECHNOLOGY FOR SOFTWARE	Cairo Al Qahirah, EG
3015426626	Aclarion, Inc.	Broomfield, CO, US
3030413550	LIFE DATA LAB, LLC	New York, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014840402. Last updated year: 2026. Please use registration number 3014840402 when referencing this establishment in official correspondence.