FDA.reportPublic FDA data

LSI MEDIENCE CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30107363183010736318LSI MEDIENCE CORPORATION1N2020-04-2513-4, Uchikanda 1-chome Chiyoda-ku Tokyo JP 101-8517

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2097101253034019K100130PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2MMI2011-05-16
2097101174295416K083412PATHFAST HSCRPDCN2009-03-09
2097101697762122K081360PATHFAST CK-MB-II, PATHFAST MYO-IIJHX2009-08-17
2097101322978716K072288PATHFAST D-DIMERGHH2009-05-06
2097101803807971K072189PATHFAST NTPROBNP AND D-DIMER TESTSNBC2008-02-05
2097101253881798
2097101675063926
2097101888139345

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MMI12011-05-16
JHX12009-08-17
GHH12009-05-06
DCN12009-03-09
NBC12008-02-05