PGDx elio plasma focus Dx
FDA 510(k) clearance DEN230046 · decided 2024-08-01
Clearance details
- K-number
- DEN230046
- Device name
- PGDx elio plasma focus Dx
- Applicant
- Personal Genome Diagnostics, Inc.
- Decision
- Unknown
- Date received
- 2023-06-30
- Decision date
- 2024-08-01
- Days to decision
- 398 days
- Clearance type
- Direct
- Product code
- SBY
- Device class
- 2
- Regulation number
- 866.6085
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Blatimore, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.