FDA 510(k) Application Details - K202304

Device Classification Name	More FDA Info for this Device
510(K) Number	K202304
Device Name	NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
Applicant	NYU Langone Medical Center 240 E 38th Street New York, NY 10016 US Other 510(k) Applications for this Company
Contact	Matija Snuderl 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	08/14/2020
Decision Date	07/14/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review