Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020704087

FEI Number

3020704087

Entity Name

Sysmex America, Inc. - Vernon Hills

City/State/Country

Vernon Hills, IL, US

Establishment Address

1011 Woodlands Parkway, Vernon Hills, IL 60061, US

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

BK210559

PMA Number

N/A

All Registered Proprietary Names

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 XE-2100DC UD-10 Sysmex XR-Series (XR-10) Automated Hematology Analyzer SP-50 SP-1000i SP-10 XN-350 XN-550 XN-430 XN-530 XN-450 XN-330 AUTOMATED HEMATOLOGY ANALYZER XW-100 UF-5000 CA-620 CA-660 XW-100 Sysmex XR-Series (XR-20) Automated Hematology Analyzer pocH-100i XS-1000iC Sysmex XN-10 Automated Hematology Analyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2011-07-06
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2025-06-27
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	2016-12-04
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2018-12-04
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2025-11-18
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2012-03-18
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2017-02-17
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2022-11-30
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2025-06-27
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2025-06-27
LKM	Counter, Urine Particle	Hematology	Class 2	864.5200	2018-05-04
GKB	Device, Automated Sedimentation Rate	Hematology	Class 1	864.5800	2025-06-27
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2012-02-20
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	2018-01-09
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2025-11-18
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	2016-08-04
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2021-08-02

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
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07
K961991	Instrumentation Laboratory CO	ACL 6000 SYSTEM (ACL 6000)	1996-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0042-05	Dade Behring Inc. Rte 896, Glasgow Business Community	2	DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Z-0043-05	bioMerieux	2	The MDA system with MDA Antithrombin III MDA Heparin

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020704087. Last updated year: 2026. Please use registration number 3020704087 when referencing this establishment in official correspondence.