FDA.reportPublic FDA data

PLANET INNOVATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30116378003011637800PLANET INNOVATION1N2026-01-01436 Elgar Road Box Hill Victoria AU 3128

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2053821504112066K183648APAS Independence with Urine Analysis ModulePPU2019-05-15
2053821544688551K180304Geri Embryo Incubator and Geri DishMQG2018-04-20
2053821310611248K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishMQG2018-06-07
2053821294808579K171736Geri Embryo Incubator and Geri DishMQG2017-11-15
2053821946175635K162911Sofia RSV FIA on Sofia 2 analyzerGQG2017-02-22
2053821161667260
2053821504112066
2053822060985487

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQG32018-06-07
PPU12019-05-15
GQG12017-02-22