Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005748564

FEI Number

3005748564

Entity Name

PRECISION SYSTEM SCIENCE COMPANY LIMITED

City/State/Country

Matsudo-city Chiba, JP

Establishment Address

88 Kamihongou, Matsudo-city Chiba 271-0064, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PRECISION SYSTEM SCIENCE COMPANY LIMITED (Owner Number: 10027605)

Owner / Operator Contact Address

88 Kamihongou, Matsudo-shi, JP-12 271-0064, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PATHFAST Elite InGenius SP 200 Elite InGenius Waste Box Elite InGenius Elite InGenius SP 200 Consumable Elite InGenius PCR Cassette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2008-11-19
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2014-10-15
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2022-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

Derek Wessman Business: Jataki Company LLC Email: usagent@jataki.com Phone: (801) 6569278

Related Public Records

Same Entity

PRECISION SYSTEM SCIENCE COMPANY LIMITED

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3042971506	PRECISION SYSTEM SCIENCE COMPANY LIMITED Odate Reagent Center	Odate-shi Akita, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0010-2019	Radiometer America Inc	1	ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Similar Registrations

Registration Number	Establishment Name	Location
3007500635	Immunodiagnostic Systems SA	Liege, BE
3008853996	Ningbo MedicalSystem Biotechnology Co., Ltd.	Ningbo Zhejiang, CN
1319809	ORTHO-CLINICAL DIAGNOSTICS, INC.	ROCHESTER, NY, US
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005748564. Last updated year: 2026. Please use registration number 3005748564 when referencing this establishment in official correspondence.