FDA.reportPublic FDA data

SYSMEX CORPORATION TECHNO PARK

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96139593002808301SYSMEX CORPORATION TECHNO PARK1N2026-01-014-4-4 TAKATSUKADAI NISHI-KU KOBE Hyogo JP 651-2271

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
155901110426848K994388XE CHECKGLQ2000-01-14
155901848643651K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERGKZ1999-11-09
155901719082701K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERGKL1998-08-14
155901533159047K961054SYSMEX UF-100LKM1996-10-28
155901246812611K960557CALIBRATION VERIFICATION ASSESSMENT (CVA)JPK1996-04-03
155901832978632K943268SCS-1000 (SYSMEX CALIBRATOR SYSTEM)KSA1994-12-15
155901537054745K852992PARA CHECK (AKA EIGHT CHECK-C)JPK1985-10-10
155901885855762K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ2025-06-25
155901803774242K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA2025-06-02
155901609244247K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ2025-06-25
155901385701676K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ2023-12-21
155901045364414K210346Sysmex XW-100 Automated Hematology AnalyzerGKZ2022-11-08
155901212912019K182389Sysmex XN-L Automated Hematology AnalyzerGKZ2019-01-25
155901859007873K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY2018-10-30
155902048654619K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ2017-11-06
155901777403764K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM2018-04-23
155901503827362K160590XN CHECKJPK2016-12-22
155901487195799K160586XN-L CHECKJPK2016-12-22
155901944308338K160541Automated 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
155901070718612K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iJPA2016-01-26
155901094432815K150678Sysmex Automated Blood Coagulation Analyzer CS-5100JPA2016-01-11
155902035153227K143577XW-100 Automated Hematology Analyzer, XW QC CHECKGKZ2015-10-12
155901880702706K141681SYSMEX XN SERIESGKZ2014-12-05
155902034466862K120747XN CAL PFKRX2012-10-22
155901824919607K120745XN CALKRX2012-10-19
155901400786079K120744XN CHECK BFJPK2012-10-19
155902069195732K120742XN CHECKJPK2012-10-19
155901130760210K112605SYSMEX XN-SERIESGKZ2012-10-19
155901421244356K091313SYSMEX MODEL XT-4000IGKZ2010-03-30
155901582735243K083200X-CALKRX2009-02-03
155901094820468K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2JJW2009-01-16
155901723249235K081610SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZERGKZ2008-08-29
155901522702637K070910SYSMEX MODEL UF1000ILKM2007-05-25
155902017120963K063218E-CHECK (XE)JPK2006-12-14
155901560510851K060656SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIESGKZ2006-05-10
155901287093300K051459SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZERGKZ2005-09-23
155901810622695K032677SYSMEX POCH-100IGKL2004-02-11
155901131324119K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560GKP2003-09-08
155901345410585K020979SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000GKP2002-06-27
155901652547753K011235SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500JPA2001-07-20
155901038840409BK210631
155901434545022BK210559
155901013929014
155901079165511
155901109337806
155901181515875
155901254725906
155901344661002
155901536407795
155901568343799
155901580211431
155901666894943
155901676958898
155901717531210
155901783397844
155901869608402
155901934960437
155902012481180
155902071277566

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ152025-06-25
JPK72016-12-22
JPA42025-06-02
LKM32018-04-23
KRX32012-10-22
GKL22004-02-11
GKP22003-09-08
JOY12018-10-30
JLW12016-10-21
JJW12009-01-16
GLQ12000-01-14
KSA11994-12-15