DEN230046
- 510(k) number
- DEN230046
- Device name
- PGDx elio plasma focus Dx
- Applicant
- Personal Genome Diagnostics, Inc. MD · US
- Product code
- SBY — High Throughput Sequencing Based Tumor Profiling Tes
- Decision date
- 2024-08-01
- Date received
- 2023-06-30
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Pathology
Official FDA record: DEN230046
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.