FDA.reportPublic FDA data

SYSMEX AMERICA, INC.

Matched from indexed company URL: SYSMEX CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14226811000515253SYSMEX AMERICA, INC.1N2026-01-01ONE SYSMEX WAY Mundelein IL US 60060
96139593002808301SYSMEX CORPORATION TECHNO PARK1N2026-01-014-4-4 TAKATSUKADAI NISHI-KU KOBE Hyogo JP 651-2271
30069494233006949423SYSMEX REAGENTS AMERICA, INC.1N2026-01-01Two Sysmex Way Mundelein IL US 60060
30077016963007701696SYSMEX CORPORATION SEISHIN FACTORY1N2026-01-014-3-2 Takatsukadai, Nishi-ku Kobe Hyogo JP 651-2271
30094956213009495621Sysmex America, Inc.1Y2026-01-01SAI - Multi-Purpose Building 1701 Leider Lane Buffalo Grove IL US 60089
30097114783009711478Sysmex America, Inc.1Y2026-01-01577 Aptakisic Rd Lincolnshire IL US 60069
30101887663010188766Sysmex RA Co., LTD, Main Office1N2026-01-013034 Hirooka-Nomura Shiojiri Nagano JP 399-0702
30109609143010960914SYSMEX CORPORATION i-SQUARE1N2026-01-01262-11 Mizuashi, Noguchicho Kakogawa Hyogo JP 675-0019
30207040873020704087Sysmex America, Inc. - Vernon Hills1Y2026-01-011011 Woodlands Parkway Vernon Hills IL US 60061

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00664369000899LYSERCELL WDF II - Lysing reagent for hematology analyzers+1(888)879-7639crc@sysmex.com
04987562205936CA CAL S - CA CAL S 3.0X3 (GCL-100A)+1(888)879-7639crc@sysmex.com
04987562408528UF II CONTROL - UF-CONTROL contains control particles for use in quality control measurement procedure of the Sysmex Fully Automated Urine Particle Analyzers and the Sysmex Fully Automated Urine Particle Digital Imaging Device.+1(888)879-7644crc@sysmex.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
155901110426848K994388XE CHECKGLQ2000-01-14
1436071110426848K994388XE CHECKGLQ2000-01-14
155901848643651K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERGKZ1999-11-09
1388271848643651K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERGKZ1999-11-09
1436071848643651K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERGKZ1999-11-09
2957881848643651K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERGKZ1999-11-09
155901719082701K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERGKL1998-08-14
1436071719082701K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERGKL1998-08-14
2957881719082701K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERGKL1998-08-14
155901533159047K961054SYSMEX UF-100LKM1996-10-28
1044821533159047K961054SYSMEX UF-100LKM1996-10-28
1729971533159047K961054SYSMEX UF-100LKM1996-10-28
155901246812611K960557CALIBRATION VERIFICATION ASSESSMENT (CVA)JPK1996-04-03
1436071246812611K960557CALIBRATION VERIFICATION ASSESSMENT (CVA)JPK1996-04-03
155901832978632K943268SCS-1000 (SYSMEX CALIBRATOR SYSTEM)KSA1994-12-15
1436071832978632K943268SCS-1000 (SYSMEX CALIBRATOR SYSTEM)KSA1994-12-15
155901537054745K852992PARA CHECK (AKA EIGHT CHECK-C)JPK1985-10-10
1436071537054745K852992PARA CHECK (AKA EIGHT CHECK-C)JPK1985-10-10
155901885855762K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ2025-06-25
1436071885855762K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ2025-06-25
1729971885855762K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ2025-06-25
2957881885855762K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ2025-06-25
155901803774242K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA2025-06-02
1436071803774242K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA2025-06-02
1729971803774242K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA2025-06-02
155901609244247K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ2025-06-25
1436071609244247K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ2025-06-25
1729971609244247K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ2025-06-25
2957881609244247K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ2025-06-25
155901385701676K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ2023-12-21
1436071385701676K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ2023-12-21
2957881385701676K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ2023-12-21
155901045364414K210346Sysmex XW-100 Automated Hematology AnalyzerGKZ2022-11-08
1436071045364414K210346Sysmex XW-100 Automated Hematology AnalyzerGKZ2022-11-08
2957881045364414K210346Sysmex XW-100 Automated Hematology AnalyzerGKZ2022-11-08
155901212912019K182389Sysmex XN-L Automated Hematology AnalyzerGKZ2019-01-25
1436071212912019K182389Sysmex XN-L Automated Hematology AnalyzerGKZ2019-01-25
155901859007873K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY2018-10-30
1436071859007873K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY2018-10-30
1729971859007873K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY2018-10-30
2957881859007873K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY2018-10-30
155902048654619K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ2017-11-06
1436072048654619K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ2017-11-06
2957882048654619K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ2017-11-06
155901777403764K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM2018-04-23
1436071777403764K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM2018-04-23
1729971777403764K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM2018-04-23
2957881777403764K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM2018-04-23
155901503827362K160590XN CHECKJPK2016-12-22
1436071503827362K160590XN CHECKJPK2016-12-22
155901487195799K160586XN-L CHECKJPK2016-12-22
1436071487195799K160586XN-L CHECKJPK2016-12-22
155901944308338K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi ControlJLW2016-10-21
1436071944308338K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi ControlJLW2016-10-21
155901388762502K160538Sysmex XN-L Automated Hematology AnalyzerGKZ2016-12-22
1388271388762502K160538Sysmex XN-L Automated Hematology AnalyzerGKZ2016-12-22
1436071388762502K160538Sysmex XN-L Automated Hematology AnalyzerGKZ2016-12-22
2957881388762502K160538Sysmex XN-L Automated Hematology AnalyzerGKZ2016-12-22
155901070718612K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iJPA2016-01-26
1436071070718612K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iJPA2016-01-26
1729971070718612K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iJPA2016-01-26
2957881070718612K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iJPA2016-01-26
155901094432815K150678Sysmex Automated Blood Coagulation Analyzer CS-5100JPA2016-01-11
1436071094432815K150678Sysmex Automated Blood Coagulation Analyzer CS-5100JPA2016-01-11
1729971094432815K150678Sysmex Automated Blood Coagulation Analyzer CS-5100JPA2016-01-11
2957881094432815K150678Sysmex Automated Blood Coagulation Analyzer CS-5100JPA2016-01-11
155902035153227K143577XW-100 Automated Hematology Analyzer, XW QC CHECKGKZ2015-10-12
1436072035153227K143577XW-100 Automated Hematology Analyzer, XW QC CHECKGKZ2015-10-12
155901880702706K141681SYSMEX XN SERIESGKZ2014-12-05
1388271880702706K141681SYSMEX XN SERIESGKZ2014-12-05
1436071880702706K141681SYSMEX XN SERIESGKZ2014-12-05
1729971880702706K141681SYSMEX XN SERIESGKZ2014-12-05
2957881880702706K141681SYSMEX XN SERIESGKZ2014-12-05
155902034466862K120747XN CAL PFKRX2012-10-22
1436072034466862K120747XN CAL PFKRX2012-10-22
155901824919607K120745XN CALKRX2012-10-19
1436071824919607K120745XN CALKRX2012-10-19
155901400786079K120744XN CHECK BFJPK2012-10-19
1436071400786079K120744XN CHECK BFJPK2012-10-19
155902069195732K120742XN CHECKJPK2012-10-19
1436072069195732K120742XN CHECKJPK2012-10-19
155901130760210K112605SYSMEX XN-SERIESGKZ2012-10-19
1388271130760210K112605SYSMEX XN-SERIESGKZ2012-10-19
1436071130760210K112605SYSMEX XN-SERIESGKZ2012-10-19
1729971130760210K112605SYSMEX XN-SERIESGKZ2012-10-19
2957881130760210K112605SYSMEX XN-SERIESGKZ2012-10-19
155901421244356K091313SYSMEX MODEL XT-4000IGKZ2010-03-30
1436071421244356K091313SYSMEX MODEL XT-4000IGKZ2010-03-30
1729971421244356K091313SYSMEX MODEL XT-4000IGKZ2010-03-30
155901582735243K083200X-CALKRX2009-02-03
1436071582735243K083200X-CALKRX2009-02-03
155901094820468K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2JJW2009-01-16
155901723249235K081610SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZERGKZ2008-08-29
1436071723249235K081610SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZERGKZ2008-08-29
2957881723249235K081610SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZERGKZ2008-08-29
1436071537825231K080887SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARELKM2008-05-02
155901522702637K070910SYSMEX MODEL UF1000ILKM2007-05-25
1044821522702637K070910SYSMEX MODEL UF1000ILKM2007-05-25
1436071522702637K070910SYSMEX MODEL UF1000ILKM2007-05-25
155902017120963K063218E-CHECK (XE)JPK2006-12-14
1436072017120963K063218E-CHECK (XE)JPK2006-12-14
155901560510851K060656SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIESGKZ2006-05-10
1436071560510851K060656SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIESGKZ2006-05-10
155901287093300K051459SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZERGKZ2005-09-23
1388271287093300K051459SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZERGKZ2005-09-23
1436071287093300K051459SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZERGKZ2005-09-23
2957881287093300K051459SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZERGKZ2005-09-23
155901810622695K032677SYSMEX POCH-100IGKL2004-02-11
1436071810622695K032677SYSMEX POCH-100IGKL2004-02-11
2957881810622695K032677SYSMEX POCH-100IGKL2004-02-11
155901131324119K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560GKP2003-09-08
1436071131324119K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560GKP2003-09-08
1496461131324119K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560GKP2003-09-08
2957881131324119K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560GKP2003-09-08
155901345410585K020979SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000GKP2002-06-27
1729971345410585K020979SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000GKP2002-06-27
155901652547753K011235SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500JPA2001-07-20
1044821652547753K011235SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500JPA2001-07-20
1436071652547753K011235SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500JPA2001-07-20
155901038840409BK210631

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ512025-06-25
JPA142025-06-02
JPK142016-12-22
LKM112018-04-23
KRX62012-10-22
GKL62004-02-11
GKP62003-09-08
JOY42018-10-30
JLW22016-10-21
GLQ22000-01-14
KSA21994-12-15
JJW12009-01-16

PMN#

49 records. Showing 1-40. Next

GUDID#

XQ-520 XQ-Series Automated Hematology Analyzer - The XQ-Series analyzer (XQ-520) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-520 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#

SYSMEX CORPORATION

2025-01-14

XQ-320 XQ-Series Automated Hematology Analyzer - The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, R DW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.

SYSMEX CORPORATION

2024-05-24

156 records. Showing 1-40. Next