510(k) DEN230046

Device

PGDx elio plasma focus Dx

Applicant

Personal Genome Diagnostics, Inc.

510(k) number

DEN230046

Product code

SBY

Decision

Unknown (DENG)

Decision date

2024-08-01

Date received

2023-06-30

Regulation

866.6085

Classification name

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

Medical specialty

Pathology

Review panel

Pathology

Device class

2

Clearance type

Direct

Third party reviewed

N