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Data / Medical devices / Japan / Sysmex Corporation Techno Park

Sysmex Corporation Techno Park: FDA-registered device maker in KOBE Hyogo, Japan, 34 510(k) clearances

Sysmex Corporation Techno Park is registered with the FDA (registration 9613959) in KOBE Hyogo, Japan. It lists 30 device types. The FDA files 34 510(k) clearances under its listings, the newest dated June 25, 2025. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Sysmex Corporation Techno Park
FDA registration number
9613959
FEI number
3002808301
Address
4-4-4 Takatsukadai Nishi-Ku, KOBE Hyogo, Japan, 651-2271
Owner or operator
SYSMEX CORPORATION (9014170)
Roles
Specification developer
First device listed
May 6, 1998
Registered through
2027
Brand names listed
AUTOMATED HEMATOLOGY ANALYZER XW-100, AUW TRACK, AlphaN-SPSU, AlphaN-XESU, Automated Blood Coagulation Analyzer CN-3000, Automated Blood Coagulation Analyzer CN-6000, Automated Immunoassay System HISCL-800, BT-50 and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Specification developeraccessdata.fda.gov
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisPER1Specification developeraccessdata.fda.gov
Calibrator For Cell IndicesKRX2Specification developeraccessdata.fda.gov
Calibrator For Red-Cell And White-Cell CountingKSA2Specification developeraccessdata.fda.gov
Calibrator, SecondaryJIT2Specification developeraccessdata.fda.gov
Calibrator, SurrogateJIW2Specification developeraccessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical UseJQC1Specification developeraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Specification developeraccessdata.fda.gov
Control, PlateletGJP2Specification developeraccessdata.fda.gov
Counter, Cell, Automated (Particle Counter)GKL2Specification developeraccessdata.fda.gov
Counter, Differential CellGKZ2Specification developeraccessdata.fda.gov
Counter, Urine ParticleLKM2Specification developeraccessdata.fda.gov
Device, Automated Cell-LocatingJOY2Specification developeraccessdata.fda.gov
Diluent, Blood CellGIF1Specification developeraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Specification developeraccessdata.fda.gov
General Purpose ReagentPPM1Specification developeraccessdata.fda.gov
Instrument, Coagulation, AutomatedGKP2Specification developeraccessdata.fda.gov
Medical Device Data SystemOUG1Specification developeraccessdata.fda.gov
Mixer, Blood TubeGLE1Specification developeraccessdata.fda.gov
Mixture, Control, White-Cell And Red-Cell IndicesGLQ2Specification developeraccessdata.fda.gov
Mixture, Hematology Quality ControlJPK2Specification developeraccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Specification developeraccessdata.fda.gov
Products, Red-Cell Lysing ProductsGGK1Specification developeraccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Specification developeraccessdata.fda.gov
Slide Stainer, AutomatedKPA1Specification developeraccessdata.fda.gov
Stain, ReticulocyteGJH1Specification developeraccessdata.fda.gov
Stains, HematologyKQC1Specification developeraccessdata.fda.gov
System, Multipurpose For In Vitro Coagulation StudiesJPA2Specification developeraccessdata.fda.gov
Timer, General LaboratoryJBS1Specification developeraccessdata.fda.gov
Urinalysis Controls (Assayed And Unassayed)JJW1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 25, 2025K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
June 25, 2025K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
June 2, 2025K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPASubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
December 21, 2023K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
November 8, 2022K210346Sysmex XW-100 Automated Hematology AnalyzerGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
January 25, 2019K182389Sysmex XN-L Automated Hematology AnalyzerGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
October 30, 2018K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOYSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
April 23, 2018K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKMSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
November 6, 2017K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
December 22, 2016K160590XN CHECKJPKSubstantially EquivalentStreckaccessdata.fda.gov
December 22, 2016K160586XN-L CHECKJPKSubstantially EquivalentStreckaccessdata.fda.gov
December 22, 2016K160538Sysmex XN-L Automated Hematology AnalyzerGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
October 21, 2016K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi ControlJLWSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
January 26, 2016K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iJPASubstantially EquivalentSiemens Healthcare Diagnostics Products GmbHaccessdata.fda.gov
January 11, 2016K150678Sysmex Automated Blood Coagulation Analyzer CS-5100JPASubstantially EquivalentSiemens Healthcare Diagnostic Products GmbHaccessdata.fda.gov
October 12, 2015K143577XW-100 Automated Hematology Analyzer, XW QC CHECKGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
December 5, 2014K141681SYSMEX XN SERIESGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
October 22, 2012K120747XN CAL PFKRXSubstantially EquivalentStreckaccessdata.fda.gov
October 19, 2012K120745XN CALKRXSubstantially EquivalentStreckaccessdata.fda.gov
October 19, 2012K120744XN CHECK BFJPKSubstantially EquivalentStreckaccessdata.fda.gov
October 19, 2012K120742XN CHECKJPKSubstantially EquivalentStreckaccessdata.fda.gov
October 19, 2012K112605SYSMEX XN-SERIESGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
February 3, 2009K083200X-CALKRXSubstantially EquivalentStreckaccessdata.fda.gov
January 16, 2009K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2JJWSubstantially EquivalentCliniqa Corporationaccessdata.fda.gov
December 14, 2006K063218E-CHECK (XE)JPKSubstantially EquivalentStreckaccessdata.fda.gov
February 11, 2004K032677SYSMEX POCH-100IGKLSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
September 8, 2003K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560GKPSubstantially EquivalentDade Behring, Inc.accessdata.fda.gov
June 27, 2002K020979SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000GKPSubstantially EquivalentDade Behring, Inc.accessdata.fda.gov
July 20, 2001K011235SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500JPASubstantially EquivalentDade Behring, Inc.accessdata.fda.gov
January 14, 2000K994388XE CHECKGLQSubstantially EquivalentStreck Laboratories, Inc.accessdata.fda.gov
August 14, 1998K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERGKLSubstantially EquivalentSysmex Corp.accessdata.fda.gov
April 3, 1996K960557CALIBRATION VERIFICATION ASSESSMENT (CVA)JPKSubstantially EquivalentStreck Laboratories, Inc.accessdata.fda.gov
December 15, 1994K943268SCS-1000 (SYSMEX CALIBRATOR SYSTEM)KSASubstantially EquivalentStreck Laboratories, Inc.accessdata.fda.gov
October 10, 1985K852992PARA CHECK (AKA EIGHT CHECK-C)JPKSubstantially EquivalentStreck Laboratories, Inc.accessdata.fda.gov

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Updated June 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.