PGDx elio plasma focus Dx— 510(k) DEN230046
UnknownPersonal Genome Diagnostics, Inc.
FDA 510(k) clearance DEN230046 for PGDx elio plasma focus Dx, Unknown on 2024-08-01. Applicant: Personal Genome Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Personal Genome Diagnostics, Inc.
- Product code
- Code SBY
- Device class
- Class 2
- Regulation
- 21 CFR 866.6085
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Blatimore, MD, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.