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Data / Medical devices / United States / Sysmex America, Inc.

Sysmex America, Inc.: FDA-registered device maker in Buffalo Grove, IL, United States, 15 510(k) clearances

Sysmex America, Inc. is registered with the FDA (registration 3009495621) in Buffalo Grove, IL, United States. It lists 22 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 25, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Sysmex America, Inc.
FDA registration number
3009495621
Address
SAI - Multi-Purpose Building 1701 Leider Lane, Buffalo Grove, IL, United States, 60089
Owner or operator
SYSMEX CORPORATION (9014170)
Roles
Contract manufacturer, Manufacturer
First device listed
May 21, 2008
Registered through
2027
Brand names listed
AUTOMATED HEMATOLOGY ANALYZER XW-100, AlphaN-SPSU, AlphaN-XESU, BT-50, Barcode Terminal (BT-40), CA-620, CA-660, CF-60 and more

Devices it lists

DeviceProduct codeClassRoleSource
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisPER1Manufactureraccessdata.fda.gov
Automated Urinalysis SystemKQO1Contract manufactureraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Contract manufactureraccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Contract manufactureraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Contract manufactureraccessdata.fda.gov
Counter, Cell, Automated (Particle Counter)GKL2Manufactureraccessdata.fda.gov
Counter, Differential CellGKZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Counter, Urine ParticleLKM2Manufactureraccessdata.fda.gov
Device, Automated Cell-LocatingJOY2Contract manufacturer, Manufactureraccessdata.fda.gov
Device, Automated Sedimentation RateGKB1Contract manufactureraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Contract manufactureraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Contract manufactureraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Contract manufactureraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Manufactureraccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Contract manufactureraccessdata.fda.gov
Instrument, Coagulation, AutomatedGKP2Manufactureraccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Contract manufactureraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Contract manufactureraccessdata.fda.gov
Refractometer For Clinical UseJRE1Contract manufactureraccessdata.fda.gov
Slide Stainer, AutomatedKPA1Manufactureraccessdata.fda.gov
System, Multipurpose For In Vitro Coagulation StudiesJPA2Manufactureraccessdata.fda.gov
Test, Urine LeukocyteLJX1Contract manufactureraccessdata.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
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
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, 2016K160538Sysmex XN-L Automated Hematology AnalyzerGKZSubstantially 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
December 5, 2014K141681SYSMEX XN SERIESGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
October 19, 2012K112605SYSMEX XN-SERIESGKZSubstantially EquivalentSysmex America, Inc.accessdata.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
August 14, 1998K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERGKLSubstantially EquivalentSysmex Corp.accessdata.fda.gov

Compare with other makers

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.