Total clearances
2
2020-04-24 → 2024-08-01
Name variants in FDA filings: Personal Genome Diagnostics, Inc. / Personal Genome Diagnostics
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| SBY |
High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids |
Class II |
Pathology |
1 |
2024-08-01 |
| PZM |
Next Generation Sequencing Based Tumor Profiling Test |
Class II |
Pathology |
1 |
2020-04-24 |
Class III
PMA approvals (1)
Total PMA records
1
Originals + supplements
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
| 2026-07-30 |
P250036 |
PGDx elio tissue complete CDx |
Original |
PQP |
— |
— |
Filings
All 510(k) clearances (2)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2024-08-01 |
DEN230046 |
PGDx elio plasma focus Dx |
SBY |
Class II |
Pathology |
| 2020-04-24 |
K192063 |
PGDx elio tissue complete |
PZM |
Class II |
Pathology |