Clearance Summary
PGDx elio tissue complete received FDA 510(k) clearance under submission number K192063, sponsored by Personal Genome Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2020-04-24.
- Submission: K192063
- Applicant / Sponsor: Personal Genome Diagnostics
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 866.6080
- Decision date: 2020-04-24
Classification & Regulation
This clearance is catalogued under FDA product code PZM and 21 CFR 866.6080, within the Pathology review panel as a Class II device.