FDA.reportPublic FDA data

Simon C. Shorter

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30027592883002759288Simon C. Shorter1N2026-01-01577 APTAKISIC RD Lincolnshire IL US 60069
30056264223005626422Simon C. Shorter1N2026-01-01577 APTAKISIC RD Lincolnshire IL US 60069
30085267323008526732Simon C. Shorter1N2026-01-01577 APTAKISIC RD Lincolnshire IL US 60069
30101887383002808299Simon C. Shorter1N2026-01-01577 APTAKISIC RD Lincolnshire IL US 60069
30104213843010421384Simon C. Shorter1N2026-01-01577 APTAKISIC RD Lincolnshire IL US 60069

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1652331848643651K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERGKZ1999-11-09
1044801848643651K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERGKZ1999-11-09
1044801719082701K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERGKL1998-08-14
1652331719082701K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERGKL1998-08-14
1652331885855762K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ2025-06-25
1652331803774242K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA2025-06-02
1652331609244247K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ2025-06-25
1044801385701676K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ2023-12-21
1652331385701676K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ2023-12-21
1652331045364414K210346Sysmex XW-100 Automated Hematology AnalyzerGKZ2022-11-08
1044801045364414K210346Sysmex XW-100 Automated Hematology AnalyzerGKZ2022-11-08
1044801212912019K182389Sysmex XN-L Automated Hematology AnalyzerGKZ2019-01-25
1652331859007873K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY2018-10-30
1652332048654619K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ2017-11-06
1044802048654619K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ2017-11-06
1652331777403764K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM2018-04-23
1652331944308338K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi ControlJLW2016-10-21
1044801388762502K160538Sysmex XN-L Automated Hematology AnalyzerGKZ2016-12-22
1652331388762502K160538Sysmex XN-L Automated Hematology AnalyzerGKZ2016-12-22
1652331070718612K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iJPA2016-01-26
1652331094432815K150678Sysmex Automated Blood Coagulation Analyzer CS-5100JPA2016-01-11
1652331880702706K141681SYSMEX XN SERIESGKZ2014-12-05
1652331130760210K112605SYSMEX XN-SERIESGKZ2012-10-19
1652331421244356K091313SYSMEX MODEL XT-4000IGKZ2010-03-30
1044801723249235K081610SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZERGKZ2008-08-29
1652331723249235K081610SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZERGKZ2008-08-29
1652331522702637K070910SYSMEX MODEL UF1000ILKM2007-05-25
1652331560510851K060656SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIESGKZ2006-05-10
1044801560510851K060656SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIESGKZ2006-05-10
1652331287093300K051459SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZERGKZ2005-09-23
1044801287093300K051459SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZERGKZ2005-09-23
1044801810622695K032677SYSMEX POCH-100IGKL2004-02-11
1652331810622695K032677SYSMEX POCH-100IGKL2004-02-11
1652331131324119K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560GKP2003-09-08
1044801345410585K020979SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000GKP2002-06-27
1652331345410585K020979SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000GKP2002-06-27
1652331652547753K011235SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500JPA2001-07-20
1652331038840409BK210631
1652331434545022BK210559
1204601013929014
1044801254725906
1652331013929014
1496431013929014
1245131013929014
1652331109337806
1652331181515875
1652331254725906
1496431344661002
1652331344661002
1245131344661002
1496431536407795
1204601536407795
1245131536407795
1652331536407795
1652331568343799
1204601580211431
1652331580211431
1245131580211431
1496431580211431
1245131624318494
1245131666894943
1496431666894943
1652331666894943
1652331869608402
1496431869608402
1652331934960437
1652332012481180

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ222025-06-25
JPA42025-06-02
GKL42004-02-11
GKP32003-09-08
LKM22018-04-23
JOY12018-10-30
JLW12016-10-21