FDA.reportPublic FDA data

Simon C. Shorter

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96139593002808301Simon C. Shorter1N2027-01-01577 APTAKISIC RD Lincolnshire IL US 60069
30056264223005626422Simon C. Shorter1N2027-01-01577 APTAKISIC RD Lincolnshire IL US 60069
30077016963007701696Simon C. Shorter1N2027-01-01577 APTAKISIC RD Lincolnshire IL US 60069

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
1044821533159047K961054SYSMEX 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
1044821522702637K070910SYSMEX 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
1044821652547753K011235SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500JPA2001-07-20
155901038840409BK210631
155901434545022BK210559
155901013929014
1245131013929014
155901079165511
1044821109337806
155901109337806
155901181515875
155901254725906
155901344661002
1245131344661002
155901536407795
1245131536407795
155901568343799
155901580211431
1245131580211431
1245131624318494
1245131666894943
155901666894943
155901676958898
155901717531210
155901783397844
155901869608402
155901934960437
155902012481180
1044822012481180
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
JPA52025-06-02
LKM52018-04-23
KRX32012-10-22
GKL22004-02-11
GKP22003-09-08
JOY12018-10-30
JLW12016-10-21
JJW12009-01-16
GLQ12000-01-14
KSA11994-12-15