Personal Genome Diagnostics

FDA Filings

This page includes the latest FDA filings for Personal Genome Diagnostics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3011805506
FEI Number3011805506
NamePERSONAL GENOME DIAGNOSTICS
Owner & OperatorPersonal Genome Diagnostics
Contact Address3600 Boston Street
Baltimore MD 21224 US
Official Correspondent
  • Jennifer Dickey
  • 1-443-6028833-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3600 Boston Street
Baltimore, MD 21224 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Personal Genome Diagnostics
PGDx Elio Tissue Complete2020-04-24
PERSONAL GENOME DIAGNOSTICS
PGDx elio diversiPhi2020-02-04

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