Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1023991398
Device Listing 1023991398
Listing Summary
#
Listing key
1023991398
Premarket submission
DEN230046
Device
PGDx elio plasma focus Dx
Applicant
Personal Genome Diagnostics, Inc.
Product code
SBY
Decision date
2024-08-01
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
226984
3011805506
3011805506
PERSONAL GENOME DIAGNOSTICS INC.
1
N
2026-01-01
3600 Boston Street Baltimore MD US 21224