510(k) DEN230046
- Device
- PGDx elio plasma focus Dx
- Applicant
- Personal Genome Diagnostics, Inc.
- 510(k) number
- DEN230046
- Product code
- SBY
- Decision
- Unknown (DENG)
- Decision date
- 2024-08-01
- Date received
- 2023-06-30
- Regulation
- 866.6085
- Classification name
- High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jennifer Dickey
- Address
- 3600 Boston St. Suite 10 Blatimore MD US 21224 21224
FDA Registration Numbers#
- 3011805506
Source Documents#
510(k) summary PDF not indicated by FDA