Identifiers
- 510(k) Number
- DEN230046 FDA 510(k)
- FDA Product Code
- SBY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.6085 FDA 510(k)
- Regulation Number
- 866.6085 FDA 510(k)
- Advisory Committee
- Pathology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
PGDx elio plasma focus Dx by Personal Genome Diagnostics, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN230046 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Personal Genome Diagnostics, Inc.
Sources (1)
- FDA 510(k) DEN230046 24 fields · synced Jun 18, 2026