FDA.reportPublic FDA data

Ikonisys, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30055660463005566046Ikonisys, Inc1N2026-01-015 Science Park New Haven CT US 06511

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
775091138364921K080909ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000NTH2008-10-17
775091695356839K062755IKONISCOPE ONCOFISH BLADDER TEST SYSTEMJOY2007-01-04
775091652196843K061392IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEMJOY2006-08-01
775092021998985K052577IKONISCOPE FASTFISH AMNIO IMAGING SYSTEMJOY2006-01-24
775091299042501

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JOY32007-01-04
NTH12008-10-17

PMN#