FDA.reportPublic FDA data

SYSMEX CORPORATION KAKOGAWA FACTORY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30027592883002759288SYSMEX CORPORATION KAKOGAWA FACTORY1N2027-01-01314-2 Kitano, Noguchi-cho Kakogawa Hyogo JP 675-0011

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1044801848643651K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERGKZ1999-11-09
1044801719082701K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERGKL1998-08-14
1044801385701676K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ2023-12-21
1044801045364414K210346Sysmex XW-100 Automated Hematology AnalyzerGKZ2022-11-08
1044801212912019K182389Sysmex XN-L Automated Hematology AnalyzerGKZ2019-01-25
1044802048654619K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ2017-11-06
1044801388762502K160538Sysmex XN-L Automated Hematology AnalyzerGKZ2016-12-22
1044801723249235K081610SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZERGKZ2008-08-29
1044801560510851K060656SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIESGKZ2006-05-10
1044801287093300K051459SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZERGKZ2005-09-23
1044801810622695K032677SYSMEX POCH-100IGKL2004-02-11
1044801345410585K020979SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000GKP2002-06-27
1044801254725906

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ92023-12-21
GKL22004-02-11
GKP12002-06-27