FDA 510(k) Application Details - DEN230046

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230046
Device Name	PGDx elio plasma focus Dx
Applicant	Personal Genome Diagnostics, Inc. 3600 Boston Street Suite 10 Baltimore, MD 21224 US Other 510(k) Applications for this Company
Contact	Jennifer Dickey Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2023
Decision Date	08/01/2024
Decision	DENG -
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review