Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009711478

FEI Number

3009711478

Entity Name

Sysmex America, Inc.

City/State/Country

Lincolnshire, IL, US

Establishment Address

577 Aptakisic Rd, Lincolnshire, IL 60069, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K081610

PMA Number

N/A

All Registered Proprietary Names

XP-300 Sysmex XR-Series (XR-20) Automated Hematology Analyzer XN-20 XN-10 pocH-100i e-CHECK(XS) e-CHECK XW-100 Barcode Terminal (BT-40) ST-41 ST-42 CV-60 ST-40 CV-50 CV-55 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 CA-620 CA-660 UD-10 XN-L CHECK 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 EIGHTCHECK-3WP IQAS EIGHTCHECK-3WP 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 XW QC CHECK XN-350 XN-550 XN-430 XN-530 XN-450 XN-330 HISCL Immuno Multi Control HISCL TSH Calibrator Automated Immunoassay System HISCL-800 HISCL TSH Assay Kit Urinalysis Data Manager (UDM) Sysmex WAM (Work Area Management) SB Cuvette Reaction Tube Cuvette XT-4000i XE-2100D XN CHECK XS-Series (XS-800i, XS-1000i) SP-50 SP-1000i SP-10 Pneumatic Unit (PU-17) UF-1000i XN CAL PF XE-2100DC UF-CALIBRATOR UF-1000i UF WAM Platelet CHECK X-CAL Calibrator UF-5000 AUTOMATED HEMATOLOGY ANALYZER XW-100 CA CAL S XN CHECK BF XQ-Series (XQ-520) Automated Hematology Analyzer XQ-Series (XQ-320) Automated Hematology Analyzer Sysmex XN-L Automated Hematology Analyzer XN-550 XN-330 XN-450 XN-350 XN-430 XN-530 Sysmex XR-Series (XR-10) Automated Hematology Analyzer UFII SEARCH-SED UFII SEARCH-BAC UF-Fluorocell CR UF-Fluorocell SF Caresphere Workflow Solution SCS-1000 Calibrator Automated Blood Coagulation Analyzer CN-6000 Automated Blood Coagulation Analyzer CN-3000 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 XN-11 XN CAL XS-1000iC

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	2025-11-18
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-10-29
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
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
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2018-01-09
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2016-12-01
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	1998-05-06
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2012-02-20
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2018-12-04
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2017-02-07
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2011-07-06
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2013-12-06
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2007-05-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2018-02-09
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2018-02-09
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2017-02-17
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2025-03-17
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2025-03-17
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2025-03-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2025-03-17
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2011-12-30
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2024-03-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2010-08-24
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-03-17
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2020-12-04
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2008-05-21
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2012-03-18
GLE	Mixer, Blood Tube	Clinical Chemistry	Class 1	862.2050	2016-12-01
LKM	Counter, Urine Particle	Hematology	Class 2	864.5200	2008-03-17
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2013-12-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2016-12-04
JIW	Calibrator, Surrogate	Clinical Chemistry	Class 2	862.1150	2018-05-08
LKM	Counter, Urine Particle	Hematology	Class 2	864.5200	2008-05-21
GJP	Control, Platelet	Hematology	Class 2	864.8625	2021-11-24
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2013-12-06
LKM	Counter, Urine Particle	Hematology	Class 2	864.5200	2018-05-04
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	2012-02-20
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2013-12-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2024-05-22
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2021-08-02
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2025-11-18
GJH	Stain, Reticulocyte	Hematology	Class 1	864.1850	2012-08-17
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2000-01-13
KSA	Calibrator For Red-Cell And White-Cell Counting	Hematology	Class 2	864.8185	2013-12-06
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2025-07-18
PER	Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis	Clinical Chemistry	Class 1	862.2750	2019-07-29
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2007-05-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2014-12-17
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2013-12-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2016-08-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K961991	Instrumentation Laboratory CO	ACL 6000 SYSTEM (ACL 6000)	1996-09-04
K850376	Terumo Medical Corp.	TERUMO SENSIBEAD EIA TSH KIT	1985-03-04

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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9613959	SYSMEX CORPORATION TECHNO PARK	KOBE Hyogo, JP
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009711478. Last updated year: 2026. Please use registration number 3009711478 when referencing this establishment in official correspondence.