FDA 510(k) Application Details - K192063

Device Classification Name	More FDA Info for this Device
510(K) Number	K192063
Device Name	PGDx elio tissue complete
Applicant	Personal Genome Diagnostics 2809 Boston Street, Suite 503 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	PZM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2019
Decision Date	04/24/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review