Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002759288

FEI Number

3002759288

Entity Name

SYSMEX CORPORATION KAKOGAWA FACTORY

City/State/Country

Kakogawa Hyogo, JP

Establishment Address

314-2 Kitano, Noguchi-cho, Kakogawa Hyogo 675-0011, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SYSMEX CORPORATION (Owner Number: 9014170)

Owner / Operator Contact Address

4-4-4 TAKATSUKADAI, NISHI-KU, KOBE, JP-NOTA 651-2271, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K992875

PMA Number

N/A

All Registered Proprietary Names

pocH-100i XS-Series (XS-800i, XS-1000i) AUTOMATED HEMATOLOGY ANALYZER XW-100 XW-100 XN-350 XN-550 XN-430 XN-530 XN-450 XN-330 XE-2100DC Option Sampler SA-90 XS-1000i sampler (OPSU-11) HST-N SA-31 Barcode Terminal (BT-40) ST-40 SA-30 AlphaN-SPSU CV-65 RB-10 Pneumatic Unit (PU-17) SA-02 RU-10 ST-42 SA-10 SA-20 SA-21 ST-41 CV-60 SA-01 CF-70 CV-50 RR-20 RR-10 COMPLETE OPSU-6 CV-55 AlphaN-XESU RU-21 TS-10 RU-20 CV-70 TU-40 CF-60 SA-51 U-RDU CV-11 TH-11 BT-50 TS-01 Automated Tube Sorter TA-01 Automated Tube Archiver Urine Sample Transportation Unit ST-10 Urine Sample Transportation Unit ST-11 Urine Sample Transportation Unit ST-12 Sysmex XN-L Automated Hematology Analyzer XN-550 XN-330 XN-450 XN-350 XN-430 XN-530 XP-300 XE-2100D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-05-21
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	Class 2	864.5200	2008-05-21
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-05-21
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2022-11-30
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2018-01-09
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2017-02-17
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2016-12-04
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2011-07-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2021-08-02
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-05-21
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	Class 2	864.5200	2008-05-21
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-03-17

Official Correspondent

No official correspondent registered.

US Agent Details

Simon C. Shorter Business: SYSMEX AMERICA, INC Email: shorters@sysmex.com Phone: (408) 8380220

Related Public Records

Same Entity

SYSMEX CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1422681	SYSMEX AMERICA, INC.	Mundelein, IL, US
3009495621	Sysmex America, Inc.	Buffalo Grove, IL, US
3008526732	SYSMEX DO BRASIL IND E COM LTDA	Sao Jose dos Pinhais Parana, BR
3010188738	SYSMEX CORPORATION ONO FACTORY	Ono Hyogo, JP
3006949423	SYSMEX REAGENTS AMERICA, INC.	Mundelein, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002759288. Last updated year: 2026. Please use registration number 3002759288 when referencing this establishment in official correspondence.