Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010421384

FEI Number

3010421384

Entity Name

SYSMEX CORPORATION

City/State/Country

KOBE Hyogo, JP

Establishment Address

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

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

K060656

PMA Number

N/A

All Registered Proprietary Names

Sysmex XR-Series (XR-20) Automated Hematology Analyzer XT-4000i 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 UF-5000 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 HISCL-5000 CS-2500 XP-300 pocH-100i Sysmex XN-10 Automated Hematology Analyzer CS-5100 XN-350 XN-550 XN-430 XN-530 XN-450 XN-330 SB Cuvette Reaction Tube Cuvette XE-2100D Sysmex XN-10 Automated Hematology Analyzer SP-50 SP-1000i SP-10 UFII SEARCH-SED UFII SEARCH-BAC UF-Fluorocell CR UF-Fluorocell SF 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 Automated Blood Coagulation Analyzer CN-6000 Automated Blood Coagulation Analyzer CN-3000 CA-7000 UF-CONTROL UF II CALIBRATOR XS-Series (XS-800i, XS-1000i)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2025-11-18
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2010-08-24
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2007-05-07
LKM	Counter, Urine Particle	Hematology	Class 2	864.5200	2018-05-04
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2007-05-07
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2025-04-29
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2016-02-03
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
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	Class 2	864.5200	2008-05-21
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2022-11-30
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2016-01-18
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2017-02-17
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2024-03-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-03-17
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2021-08-02
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2012-03-18
GJH	Stain, Reticulocyte	Hematology	Class 1	864.1850	2012-08-17
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	2025-07-18
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2012-02-20
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-05-04
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-05-21

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
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18
K961991	Instrumentation Laboratory CO	ACL 6000 SYSTEM (ACL 6000)	1996-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2025	Becton, Dickinson and Company, BD Bio Sciences	1	BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.
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).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010421384. Last updated year: 2026. Please use registration number 3010421384 when referencing this establishment in official correspondence.