FDA.reportPublic FDA data

SYSMEX CORPORATION SEISHIN FACTORY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30077016963007701696SYSMEX CORPORATION SEISHIN FACTORY1N2026-01-014-3-2 Takatsukadai, Nishi-ku Kobe Hyogo JP 651-2271

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1044821533159047K961054SYSMEX UF-100LKM1996-10-28
1044821522702637K070910SYSMEX MODEL UF1000ILKM2007-05-25
1044821652547753K011235SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500JPA2001-07-20
1044821109337806
1044822012481180

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LKM22007-05-25
JPA12001-07-20