FDA.reportPublic FDA data

PERSONAL GENOME DIAGNOSTICS INC.

Matched from indexed company URL: Personal Genome Diagnostics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30118055063011805506PERSONAL GENOME DIAGNOSTICS INC.1N2026-01-013600 Boston Street Baltimore MD US 21224

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2269841920991602K192063PGDx elio tissue completePZM2020-04-24
2269841023991398DEN230046PGDx elio plasma focus DxSBY2024-08-01
2269841404058844
2269841926001817
2269842050972836

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SBY12024-08-01
PZM12020-04-24

PMN#

GUDID#