# Personal Genome Diagnostics, Inc.

- Location (FDA's records): Baltimore, MD
- FDA decisions: 3 (2020–2026): 1 510(k) clearance, 1 De Novo grant and 1 original PMA approval
- Names in FDA's records: Personal Genome Diagnostics, Inc. (2); Personal Genome Diagnostics (1)
- Product codes: PZM (1), SBY (1), PQP (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Memorial Sloan-Kettering Cancer Center: 1 (https://510kreport.com/company/memorial-sloan-kettering-cancer-center)

## Firms that cite its devices most
- Geneseeq Technology, Inc.: 1 (https://510kreport.com/company/geneseeq-technology)

## Its most-cited devices
- K192063: PGDx elio tissue complete (2020), cited by 1

## Recent decisions
- P250036: PGDx elio tissue complete CDx (Jul 30, 2026)
- DEN230046: PGDx elio plasma focus Dx (Aug 1, 2024)
- K192063: PGDx elio tissue complete (Apr 24, 2020)

Source page: https://510kreport.com/company/personal-genome-diagnostics