The following data is part of a premarket notification filed by Personal Genome Diagnostics with the FDA for Pgdx Elio Tissue Complete.
| Device ID | K192063 |
| 510k Number | K192063 |
| Device Name: | PGDx Elio Tissue Complete |
| Classification | Next Generation Sequencing Based Tumor Profiling Test |
| Applicant | Personal Genome Diagnostics 2809 Boston Street, Suite 503 Baltimore, MD 21224 |
| Contact | Jennifer Dickey |
| Correspondent | Jennifer Dickey Personal Genome Diagnostics 2809 Boston Street, Suite 503 Baltimore, MD 21224 |
| Product Code | PZM |
| CFR Regulation Number | 866.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-01 |
| Decision Date | 2020-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00192721001418 | K192063 | 000 |
| 00192721000770 | K192063 | 000 |
| 00192721000763 | K192063 | 000 |
| 00192721000756 | K192063 | 000 |
| 00192721001432 | K192063 | 000 |
| 00192721001456 | K192063 | 000 |
| 00192721001449 | K192063 | 000 |