FDA.reportPublic FDA data

MIE AMERICA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14233483000210013MIE AMERICA, INC.1N2026-01-01420 BENNETT RD. ELK GROVE VILLAGE IL US 60007

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
168401232403501K953193SCINTRON IVKPS1995-10-24
168401674444044K201807ANCORISKPS2020-08-27
168401253555912K130269ECAT SCINTRON PETKPS2013-04-19
168401903251882K101768MIE SCINTRON GAMMA CAMERA SYSTEMSKPS2010-10-05
168401926104357K101013MODIFICATION TO SCINTRON IVKPS2010-06-07
168401301466187K053086MIE - GAMMA CAMERA SYSTEMSKPS2006-01-27
168401772457484

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPS62020-08-27

PMN#