meddevicedb.com FDA Device Reference

PGDx elio plasma focus Dx

DEN230046 Class II Direct
Decision Date
2024-08-01
Sponsor / Applicant
Personal Genome Diagnostics, Inc.

Technical Specification

510(k) Submission ID DEN230046
Product Code SBY
Medical Specialty / Panel Pathology
Regulation Citation 21 CFR 866.6085
Decision Date 2024-08-01
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

PGDx elio plasma focus Dx received FDA 510(k) clearance under submission number DEN230046, sponsored by Personal Genome Diagnostics, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2024-08-01.

Classification & Regulation

This clearance is catalogued under FDA product code SBY and 21 CFR 866.6085, within the Pathology review panel as a Class II device.