Personal Genome Diagnostics

FDA Regulatory Profile

Personal Genome Diagnostics appears in FDA public data with 0 recalls, 2 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 1, 2024.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
DEN230046PGDx elio plasma focus DxAugust 1, 2024
K192063PGDx elio tissue completeApril 24, 2020