Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613959

FEI Number

3002808301

Entity Name

SYSMEX CORPORATION TECHNO PARK

City/State/Country

KOBE Hyogo, JP

Establishment Address

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

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K994388

PMA Number

N/A

All Registered Proprietary Names

Sysmex XR-Series (XR-20) Automated Hematology Analyzer UF-1000i XN-L CHECK Lysercell WPC Lysercell WNR Lysercell WDF Sulfolyser Stromatolyser-4DS XW pack L Stromatolyser-IM Stromatolyser-4DL Stromatolyser-3WP Stromatolyser-WH Stromatolyser-NR Stromatolyser-FB pocH-pack L Stromatolyser-NR(L) Lysercell WDF II 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 CS-2500 SP-50 SP-1000i SP-10 XS-1000iC STROMATOLYSER NR (S) FLUOROCELL WPC FLUOROCELL WNR FLUOROCELL WDF FLUOROCELL PLT FLUOROCELL RET XE-2100D XN-20 XN-10 SB Cuvette Reaction Tube Cuvette UF-CALIBRATOR X-CAL Calibrator e-CHECK(XE) XN-11 AUTOMATED HEMATOLOGY ANALYZER XW-100 Sysmex XN-10 Automated Hematology Analyzer UF-CONTROL UF II CALIBRATOR Pneumatic Unit (PU-17) CELLPACK DFL Cellpack Cellsheath CELLSHEATH CCS UF-CELLSHEATH XW pack D UF-CELLPACK CR UF-CELLPACK SF Cellsheath C CELLPACK DCL UF II PACK SED UF II Sheath pocH-pack D CELLPACK S RETSEARCH II UF II PACK-BAC CELLPACK DST Sysmex XN-L Automated Hematology Analyzer XN-550 XN-330 XN-450 XN-350 XN-430 XN-530 CA CLEAN I CELLCLEAN CELLCLEAN AUTO Concentrated phosphate buffer for SP pH 6.6 Concentrated phosphate buffer for SP pH 7.2 Concentrated phosphate buffer for SP pH 6.8 Concentrated phosphate buffer for SP pH 7 XW CELLCLEAN CyFlow CLEAN CA CLEAN II CN-COAGWASHER Sysmex XN-10 Automated Hematology Analyzer UC-Control XN CHECK BF UF-5000 Urinalysis Data Manager (UDM) Sysmex WAM (Work Area Management) pocH-100i Platelet CHECK UD-10 EIGHTCHECK-3WP IQAS EIGHTCHECK-3WP XP-300 Barcode Terminal (BT-40) ST-41 ST-42 CV-60 ST-40 CV-50 CV-55 XE-2100DC XN CHECK XN CAL PF XS-Series (XS-800i, XS-1000i) CS-5100 XN CAL e-CHECK(XS) e-CHECK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2025-11-18
LKM	Counter, Urine Particle	Hematology	Class 2	864.5200	2008-03-17
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2017-02-07
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2007-05-07
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2011-07-06
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2016-02-03
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2012-03-18
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2016-08-04
KQC	Stains, Hematology	Hematology	Class 1	864.1850	2012-06-04
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-03-17
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-10-29
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2024-03-07
JIW	Calibrator, Surrogate	Clinical Chemistry	Class 2	862.1150	2018-05-08
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2013-12-06
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2013-12-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2014-12-17
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2022-11-30
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2021-08-02
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-05-04
GLE	Mixer, Blood Tube	Clinical Chemistry	Class 1	862.2050	2016-12-01
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2007-05-07
PER	Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis	Clinical Chemistry	Class 1	862.2750	2019-07-29
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2021-08-02
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	1998-05-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2022-11-30
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-12-19
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2013-12-06
LKM	Counter, Urine Particle	Hematology	Class 2	864.5200	2018-05-04
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2011-12-30
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
GJP	Control, Platelet	Hematology	Class 2	864.8625	2021-11-24
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2018-12-04
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2013-12-06
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
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2016-12-01
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2016-12-04
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2020-12-04
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2013-12-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-05-21
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2016-01-18
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2013-12-06
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2013-12-06
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Hematology	Class 2	864.8625	2013-12-06

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
K781077	Dade, Baxter Travenol Diagnostics, Inc.	CONTROL, HEMATOLOGY, CH-60	1978-07-27
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18
K791007	Bioscientific	STAT DIFF STAIN	1979-08-03

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.

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3002759288	SYSMEX CORPORATION KAKOGAWA FACTORY	Kakogawa Hyogo, JP
3009711478	Sysmex America, Inc.	Lincolnshire, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613959. Last updated year: 2026. Please use registration number 9613959 when referencing this establishment in official correspondence.