Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010188766

FEI Number

3010188766

Entity Name

Sysmex RA Co., LTD, Main Office

City/State/Country

Shiojiri Nagano, JP

Establishment Address

3034 Hirooka-Nomura, Shiojiri Nagano 399-0702, 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

N/A

PMA Number

N/A

All Registered Proprietary Names

CA-620 CA-660 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 AUW TRACK TS-10 RB-10 SP-50 SP-1000i SP-10

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2012-02-20
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2011-07-06
JBS	Timer, General Laboratory	Clinical Chemistry	Class 1	862.2050	2017-01-22
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2012-03-18

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
K961991	Instrumentation Laboratory CO	ACL 6000 SYSTEM (ACL 6000)	1996-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2008	Diagnostica Stago, Inc.	2	STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
Z-0135-2011	Instrumentation Laboratory Co.	2	ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Z-0136-2011	Instrumentation Laboratory Co.	2	ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-0137-2011	Instrumentation Laboratory Co.	2	ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Z-0138-2011	Instrumentation Laboratory Co.	2	ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

Similar Registrations

Registration Number	Establishment Name	Location
3037000637	INSTRUMENTATION LABORATORY CO. - Devens	Devens, MA, US
3010960914	SYSMEX CORPORATION i-SQUARE	Kakogawa Hyogo, JP
3006198300	Diamond Diagnostics Inc.	Budapest, HU
3009711478	Sysmex America, Inc.	Lincolnshire, IL, US
8043723	Diagnostica Stago - Gennevilliers	Gennevilliers Hauts-de-Seine, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010188766. Last updated year: 2026. Please use registration number 3010188766 when referencing this establishment in official correspondence.